Pub Date : 2025-12-01Epub Date: 2025-09-20DOI: 10.1016/j.jpbao.2025.100091
Abdullah Al Faysal, Beril S. Kaya, Hatice Elmacioglu, Ayşegül Gölcü
Turkey has historically been a prominent player in the trade of medicinal and aromatic plants, a status attributed to its advantageous geographical position, favorable climate, rich plant diversity, agricultural capabilities, and extensive land area. The country's flora is home to numerous species that are integral to established practices in herbal medicine, as well as the global manufacturing of plant-based chemicals, food additives, cosmetics, and perfumery. Recent research has particularly emphasized the role of antioxidant substances and phenolic compounds found in plants in promoting health. This review thoroughly evaluates the analytical techniques utilized in assessing antioxidant activity, drawing attention to the essential chemical reactions that underpin these measurements. Furthermore, the article compellingly highlights the significant role of antioxidants across various industries, demonstrating their crucial contributions to health, food preservation, and beyond. Furthermore, an in-depth analysis of the antioxidant properties of Turkish plant extracts is presented, detailing their constituent components, the solvents utilized for extraction, and the methodologies applied in antioxidant research.
{"title":"A comprehensive evaluation of contemporary techniques employed to measure the antioxidant activity of plant extracts from Turkey, both in vitro and in vivo","authors":"Abdullah Al Faysal, Beril S. Kaya, Hatice Elmacioglu, Ayşegül Gölcü","doi":"10.1016/j.jpbao.2025.100091","DOIUrl":"10.1016/j.jpbao.2025.100091","url":null,"abstract":"<div><div>Turkey has historically been a prominent player in the trade of medicinal and aromatic plants, a status attributed to its advantageous geographical position, favorable climate, rich plant diversity, agricultural capabilities, and extensive land area. The country's flora is home to numerous species that are integral to established practices in herbal medicine, as well as the global manufacturing of plant-based chemicals, food additives, cosmetics, and perfumery. Recent research has particularly emphasized the role of antioxidant substances and phenolic compounds found in plants in promoting health. This review thoroughly evaluates the analytical techniques utilized in assessing antioxidant activity, drawing attention to the essential chemical reactions that underpin these measurements. Furthermore, the article compellingly highlights the significant role of antioxidants across various industries, demonstrating their crucial contributions to health, food preservation, and beyond. Furthermore, an in-depth analysis of the antioxidant properties of Turkish plant extracts is presented, detailing their constituent components, the solvents utilized for extraction, and the methodologies applied in antioxidant research.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100091"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145157521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Biosensors utilising nanotechnology are advancing swiftly and are extensively employed across various domains, including biomedicine, environmental monitoring, and analytical chemistry, where they have attained significant roles. Novel nanomaterials are being extensively designed and produced for prospective biosensing and theranostic uses. This review provides a comprehensive analysis of relevant literature from the past ten years, focusing on the use of nanoparticles in this context. The amalgamation of diagnostic biosensors with drug delivery systems for the administration of therapeutic agents presents significant potential in next-generation theranostic platforms. The controllable, precise, and safe delivery of diagnostic biosensing devices and therapeutic drugs to target tissues, organs, or cells is a crucial factor in the development of improved nanobiosensor-based theranostic systems. Recently, the utilisation of natural biological carriers in drug delivery systems has become one of the most extensively studied research issues. Erythrocytes, or red blood cells, may serve as carriers for a diverse array of pharmaceuticals, encompassing anticancer, antibacterial, antiviral, and anti-inflammatory agents, as well as numerous proteins, peptides, enzymes, and other macromolecules. Red blood cell (RBC)-based nanocarrier systems, known as erythrocyte nanovesicles, exhibit remarkable characteristics including prolonged circulation times, evasion of the immune system, gradual drug release, protection of drugs and biosensors from endogenous factors, targeted delivery, and applications in both therapeutic and diagnostic domains within biomedical sciences. Erythrocytes, the most prevalent circulating blood cells, have been thoroughly studied for biomimetic coatings on artificial nanocarriers owing to their enhanced biocompatibility, biodegradability, non-immunogenicity, and prolonged circulation in the bloodstream. Consequently, erythrocyte nanovehicles (ENV) has many applications, including drug transport, imaging, phototherapy, immunomodulation, sensing, and detection, which indicate substantial promise for therapeutic and diagnostic uses in various disorders. This paper covers recent advancements in the biomedical uses of ENV in cancer, infections, cardiovascular issues, and several other associated ailments particularly for biosensing. This paper also presents the RBC-mediated transport of nanobiosensors for bio-imaging at the single-cell level, enhanced medical diagnostics, and the analytical detection of biomolecules and cellular activity.
{"title":"Erythrocyte-derived nanosystems for biosensing: A green approach for analysis","authors":"Shivam Rajput , Rishabha Malviya , Sathvik Belagodu Sridhar , Tarun Wadhwa , Javedh Shareef","doi":"10.1016/j.jpbao.2025.100088","DOIUrl":"10.1016/j.jpbao.2025.100088","url":null,"abstract":"<div><div>Biosensors utilising nanotechnology are advancing swiftly and are extensively employed across various domains, including biomedicine, environmental monitoring, and analytical chemistry, where they have attained significant roles. Novel nanomaterials are being extensively designed and produced for prospective biosensing and theranostic uses. This review provides a comprehensive analysis of relevant literature from the past ten years, focusing on the use of nanoparticles in this context. The amalgamation of diagnostic biosensors with drug delivery systems for the administration of therapeutic agents presents significant potential in next-generation theranostic platforms. The controllable, precise, and safe delivery of diagnostic biosensing devices and therapeutic drugs to target tissues, organs, or cells is a crucial factor in the development of improved nanobiosensor-based theranostic systems. Recently, the utilisation of natural biological carriers in drug delivery systems has become one of the most extensively studied research issues. Erythrocytes, or red blood cells, may serve as carriers for a diverse array of pharmaceuticals, encompassing anticancer, antibacterial, antiviral, and anti-inflammatory agents, as well as numerous proteins, peptides, enzymes, and other macromolecules. Red blood cell (RBC)-based nanocarrier systems, known as erythrocyte nanovesicles, exhibit remarkable characteristics including prolonged circulation times, evasion of the immune system, gradual drug release, protection of drugs and biosensors from endogenous factors, targeted delivery, and applications in both therapeutic and diagnostic domains within biomedical sciences. Erythrocytes, the most prevalent circulating blood cells, have been thoroughly studied for biomimetic coatings on artificial nanocarriers owing to their enhanced biocompatibility, biodegradability, non-immunogenicity, and prolonged circulation in the bloodstream. Consequently, erythrocyte nanovehicles (ENV) has many applications, including drug transport, imaging, phototherapy, immunomodulation, sensing, and detection, which indicate substantial promise for therapeutic and diagnostic uses in various disorders. This paper covers recent advancements in the biomedical uses of ENV in cancer, infections, cardiovascular issues, and several other associated ailments particularly for biosensing. This paper also presents the RBC-mediated transport of nanobiosensors for bio-imaging at the single-cell level, enhanced medical diagnostics, and the analytical detection of biomolecules and cellular activity.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100088"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-17DOI: 10.1016/j.jpbao.2025.100096
Maikon Thiago do Nascimento , Mayara S. Araujo , Leticia Abe de Sena , Roberta A. Medeiros , Mariana Gava Segatelli , Cesar Ricardo Teixeira Tarley
This work reports an analytical strategy for the quantification of pyridoxine (PYR) and caffeine (CAF) in pre-workout formulations, specifically multi-ingredient performance supplements (MIPS) and encapsulated guarana powder (GP). The approach relies on batch injection analysis with amperometric detection (BIA-AD) employing a boron-doped diamond electrode (BDDE) as the working electrode. A straightforward correction factor (CF) was applied to enable caffeine determination at + 1.5 V in the presence of pyridoxine. The method provided low limits of quantification, 9.64 µmol L−1 for pyridoxine and 6.82 µmol L−1 for caffeine. Accuracy was assessed through spiking and recovery assays, yielding values between 90 % and 110 %, and the results showed good agreement with those obtained by the reference High-Performance Liquid Chromatography with Diode-Array Detection technique. Application of the method to real samples demonstrated that both analytes were successfully measured in multi-ingredient performance supplements. For guarana powder samples, the caffeine concentrations were consistent with the labeled values. Overall, the method offers a rapid, low-cost, portable, and environmentally sustainable alternative for the determination of pyridoxine and caffeine in pre-workout supplements.
{"title":"A simple approach for amperometric determination of pyridoxine and caffeine in pre-workout supplements using batch injection analysis with boron-doped diamond electrode","authors":"Maikon Thiago do Nascimento , Mayara S. Araujo , Leticia Abe de Sena , Roberta A. Medeiros , Mariana Gava Segatelli , Cesar Ricardo Teixeira Tarley","doi":"10.1016/j.jpbao.2025.100096","DOIUrl":"10.1016/j.jpbao.2025.100096","url":null,"abstract":"<div><div>This work reports an analytical strategy for the quantification of pyridoxine (PYR) and caffeine (CAF) in pre-workout formulations, specifically multi-ingredient performance supplements (MIPS) and encapsulated guarana powder (GP). The approach relies on batch injection analysis with amperometric detection (BIA-AD) employing a boron-doped diamond electrode (BDDE) as the working electrode. A straightforward correction factor (CF) was applied to enable caffeine determination at + 1.5 V in the presence of pyridoxine. The method provided low limits of quantification, 9.64 µmol L<sup>−1</sup> for pyridoxine and 6.82 µmol L<sup>−1</sup> for caffeine. Accuracy was assessed through spiking and recovery assays, yielding values between 90 % and 110 %, and the results showed good agreement with those obtained by the reference High-Performance Liquid Chromatography with Diode-Array Detection technique. Application of the method to real samples demonstrated that both analytes were successfully measured in multi-ingredient performance supplements. For guarana powder samples, the caffeine concentrations were consistent with the labeled values. Overall, the method offers a rapid, low-cost, portable, and environmentally sustainable alternative for the determination of pyridoxine and caffeine in pre-workout supplements.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100096"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145578904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A robust and sensitive ultra-performance liquid chromatography (UPLC) method was developed and rigorously validated for the simultaneous quantification of rizatriptan, meloxicam, and their corresponding N-nitrosamine impurities in pharmaceutical dosage forms. Method development and optimization were conducted using a Box–Behnken Design to systematically investigate the effects of acetonitrile proportion, mobile phase flow rate, and pH on critical chromatographic responses, including retention time and tailing factor. Optimal separation was achieved with a mobile phase comprising 30 % v/v acetonitrile, a flow rate of 0.2 mL/min, and a pH of 2.5, resulting in well-resolved, symmetrical peaks. Validation performed in accordance with ICH guidelines confirmed excellent linearity (R² > 0.999) over the tested concentration ranges, low limits of detection (0.47–1.39 µg/mL), high precision (%RSD <2 %), and satisfactory accuracy (98–102 % recoveries). The method demonstrated robustness under deliberate minor variations of chromatographic parameters and maintained specificity by effectively resolving target analytes from degradation products during forced degradation studies. Sustainability and environmental impact were comprehensively assessed using ComplexGAPI, AGREE, AGREEprep, Analytical Eco-Scale, and Blue Applicability Grade Index metrics, all indicating high greenness and operational suitability. Application of the method to the commercial combination product Symbravo confirmed its capability for accurate quantification of active pharmaceutical ingredients and low-level nitrosamine impurities. Collectively, these findings underscore the method’s suitability for routine quality control, impurity profiling, and regulatory compliance in modern pharmaceutical analysis.
{"title":"A stability-indicating and environmentally sustainable UPLC method for simultaneous determination of rizatriptan, meloxicam, and related N-nitrosamine impurities","authors":"KiranKumar Chagarlamudi , Venkata Kanaka Srivani Maddala , Kumaraswamy Gandla","doi":"10.1016/j.jpbao.2025.100087","DOIUrl":"10.1016/j.jpbao.2025.100087","url":null,"abstract":"<div><div>A robust and sensitive ultra-performance liquid chromatography (UPLC) method was developed and rigorously validated for the simultaneous quantification of rizatriptan, meloxicam, and their corresponding N-nitrosamine impurities in pharmaceutical dosage forms. Method development and optimization were conducted using a Box–Behnken Design to systematically investigate the effects of acetonitrile proportion, mobile phase flow rate, and pH on critical chromatographic responses, including retention time and tailing factor. Optimal separation was achieved with a mobile phase comprising 30 % v/v acetonitrile, a flow rate of 0.2 mL/min, and a pH of 2.5, resulting in well-resolved, symmetrical peaks. Validation performed in accordance with ICH guidelines confirmed excellent linearity (R² > 0.999) over the tested concentration ranges, low limits of detection (0.47–1.39 µg/mL), high precision (%RSD <2 %), and satisfactory accuracy (98–102 % recoveries). The method demonstrated robustness under deliberate minor variations of chromatographic parameters and maintained specificity by effectively resolving target analytes from degradation products during forced degradation studies. Sustainability and environmental impact were comprehensively assessed using ComplexGAPI, AGREE, AGREEprep, Analytical Eco-Scale, and Blue Applicability Grade Index metrics, all indicating high greenness and operational suitability. Application of the method to the commercial combination product Symbravo confirmed its capability for accurate quantification of active pharmaceutical ingredients and low-level nitrosamine impurities. Collectively, these findings underscore the method’s suitability for routine quality control, impurity profiling, and regulatory compliance in modern pharmaceutical analysis.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100087"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-04DOI: 10.1016/j.jpbao.2025.100094
Michele Protti , Roberta Di Lecce , Jiri Adamec , Luca G. Regazzoni , Valeria Valsecchi , Claudia Volpi , Roberto Mandrioli , Laura Mercolini
In this study, for the first time rat plasma microsampling was carried out by means of in situ-generated volumetric dried plasma spot (vDPS) technology and applied to the determination of the neuroprotective agent edaravone and its sulphate and glucuronide metabolites. Sampling was performed using Telimmune® plasma separation cards (vPSC), which allow the formation of volumetrically accurate dried plasma spots (3 µL) from blood drops deposited on them. After accelerated forced drying and solvent extraction in methanol, drying and redissolution, analytes were baseline separated and quantified through an original HPLC-MS/MS analytical method. Validation assays provided excellent results, with detection limits between 0.7 and 1.7 ng/mL, and quantitation limits between 2.0 and 5.0 ng/mL. Extraction yields were higher than 81 % and precision was lower than 14.1 % (relative standard deviation, RSD). The volumetric microsampling approach offers a much less invasive and stressful sampling. The vPSC technology offers a simple, cost-effective alternative method to produce a volumetric plasma sample that is stable when dried and eliminates requirements for both cold-chain and biohazard transport. The developed analytical workflow appears suitable for advantageous application to pharmacokinetic and toxicokinetic animal studies of edaravone and its metabolites.
{"title":"In situ-generated volumetric dried plasma spots for the analysis of edaravone and metabolites in animal models","authors":"Michele Protti , Roberta Di Lecce , Jiri Adamec , Luca G. Regazzoni , Valeria Valsecchi , Claudia Volpi , Roberto Mandrioli , Laura Mercolini","doi":"10.1016/j.jpbao.2025.100094","DOIUrl":"10.1016/j.jpbao.2025.100094","url":null,"abstract":"<div><div>In this study, for the first time rat plasma microsampling was carried out by means of in situ-generated volumetric dried plasma spot (vDPS) technology and applied to the determination of the neuroprotective agent edaravone and its sulphate and glucuronide metabolites. Sampling was performed using Telimmune® plasma separation cards (vPSC), which allow the formation of volumetrically accurate dried plasma spots (3 µL) from blood drops deposited on them. After accelerated forced drying and solvent extraction in methanol, drying and redissolution, analytes were baseline separated and quantified through an original HPLC-MS/MS analytical method. Validation assays provided excellent results, with detection limits between 0.7 and 1.7 ng/mL, and quantitation limits between 2.0 and 5.0 ng/mL. Extraction yields were higher than 81 % and precision was lower than 14.1 % (relative standard deviation, RSD). The volumetric microsampling approach offers a much less invasive and stressful sampling. The vPSC technology offers a simple, cost-effective alternative method to produce a volumetric plasma sample that is stable when dried and eliminates requirements for both cold-chain and biohazard transport. The developed analytical workflow appears suitable for advantageous application to pharmacokinetic and toxicokinetic animal studies of edaravone and its metabolites.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100094"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145528225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-04DOI: 10.1016/j.jpbao.2025.100092
İnci Uludağ Anıl, Mustafa Kemal Sezgintürk
The emergence of anti-drug antibodies (ADAs) poses a significant challenge in biological therapeutics, undermining drug efficacy and patient safety. This review thoroughly assesses existing and novel analytical methods for ADA detection, highlighting their principles, strengths, and limitations. Conventional techniques like ELISA and ECL provide great sensitivity but may be inadequate for detecting low-affinity ADAs. On the other hand, surface plasmon resonance (SPR) offers advantages in detecting low-affinity anti-drug antibodies (ADAs) due to its real-time kinetic assessment. Recent advancements in label-free technologies, such as thin-film interferometry, electrolyte-gated organic field-effect transistors, and quartz crystal microbalance, show significant potential for rapid, sensitive, and real-time ADA monitoring. These advanced platforms enable accurate kinetic characterization and offer promise for point-of-care applications. Additionally, novel approaches address limitations of conventional immunoassays by simplifying workflows and reducing assay time. This review underscores the importance of ADA assessment for optimizing personalized therapeutic strategies and improving patient outcomes.
{"title":"Advances in anti-drug antibody detection: Miniaturized biosensor technologies and beyond","authors":"İnci Uludağ Anıl, Mustafa Kemal Sezgintürk","doi":"10.1016/j.jpbao.2025.100092","DOIUrl":"10.1016/j.jpbao.2025.100092","url":null,"abstract":"<div><div>The emergence of anti-drug antibodies (ADAs) poses a significant challenge in biological therapeutics, undermining drug efficacy and patient safety. This review thoroughly assesses existing and novel analytical methods for ADA detection, highlighting their principles, strengths, and limitations. Conventional techniques like ELISA and ECL provide great sensitivity but may be inadequate for detecting low-affinity ADAs. On the other hand, surface plasmon resonance (SPR) offers advantages in detecting low-affinity anti-drug antibodies (ADAs) due to its real-time kinetic assessment. Recent advancements in label-free technologies, such as thin-film interferometry, electrolyte-gated organic field-effect transistors, and quartz crystal microbalance, show significant potential for rapid, sensitive, and real-time ADA monitoring. These advanced platforms enable accurate kinetic characterization and offer promise for point-of-care applications. Additionally, novel approaches address limitations of conventional immunoassays by simplifying workflows and reducing assay time. This review underscores the importance of ADA assessment for optimizing personalized therapeutic strategies and improving patient outcomes.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100092"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145265852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-09-15DOI: 10.1016/j.jpbao.2025.100090
Wenning Zhu , Xinyu Liu , Yaping Zhao , Jingwei Wang , Xuwen Zhang , Chenxi Liu
Albendazole (ABZ) exists as two solid-state isomers: the amino form (Form I) and the imino form (Form II). While Form II significantly influences bioavailability, current analytical methods primarily focus on qualitative identification of polymorphs or quantify only Form I in raw materials. To address the lack of quantitative methods for both isomers in formulations, we developed a novel near-infrared (NIR) spectroscopy–based approach. This work established a validated quantitative model. ABZ Form II was prepared and characterized via X–ray diffraction, thermal analysis, and Raman imaging. Commercial albendazole tablets were simulated by spiking Form II into excipients at gradient concentrations (5–95 % w/w). The near-infrared (NIR) spectra were screened with preprocessing methods and wavenumber regions. A Factor was set that included the comprehensive determination coefficient (R2), root mean square error of cross validation (RMSECV), Bias and relative percentage deviation (RPD). Models with a Factor score < 0.5 or recovery rates outside 90–110 % were excluded. The method demonstrated high precision (RSD = 0.07 %), with LOD and LOQ values of 0.7840 ± 0.0028 % w/w and 3.0243 ± 0.0139 % w/w, respectively. In summary, this is the first reported NIR method for simultaneous quantification of ABZ Form I and Form II in tablets, providing a rapid, non–destructive tool for pharmaceutical quality control
{"title":"Quantitative analysis of Form II in albendazole formulations using near-infrared spectroscopy and partial least squares analysis","authors":"Wenning Zhu , Xinyu Liu , Yaping Zhao , Jingwei Wang , Xuwen Zhang , Chenxi Liu","doi":"10.1016/j.jpbao.2025.100090","DOIUrl":"10.1016/j.jpbao.2025.100090","url":null,"abstract":"<div><div>Albendazole (ABZ) exists as two solid-state isomers: the amino form (Form I) and the imino form (Form II). While Form II significantly influences bioavailability, current analytical methods primarily focus on qualitative identification of polymorphs or quantify only Form I in raw materials. To address the lack of quantitative methods for both isomers in formulations, we developed a novel near-infrared (NIR) spectroscopy–based approach. This work established a validated quantitative model. ABZ Form II was prepared and characterized via X–ray diffraction, thermal analysis, and Raman imaging. Commercial albendazole tablets were simulated by spiking Form II into excipients at gradient concentrations (5–95 % w/w). The near-infrared (NIR) spectra were screened with preprocessing methods and wavenumber regions. A Factor was set that included the comprehensive determination coefficient (R<sup>2</sup>), root mean square error of cross validation (RMSECV), Bias and relative percentage deviation (RPD). Models with a Factor score < 0.5 or recovery rates outside 90–110 % were excluded. The method demonstrated high precision (RSD = 0.07 %), with LOD and LOQ values of 0.7840 ± 0.0028 % w/w and 3.0243 ± 0.0139 % w/w, respectively. In summary, this is the first reported NIR method for simultaneous quantification of ABZ Form I and Form II in tablets, providing a rapid, non–destructive tool for pharmaceutical quality control</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100090"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A novel, green, and robust Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed and validated for the simultaneous quantification of sulopenem etzadroxil and probenecid in rat plasma, with application to pharmacokinetic studies. Method development was guided by a Box–Behnken Design and response surface methodology, optimizing key chromatographic variables—ethanol proportion (40–60 %), flow rate (0.8–1.2 mL/min), and mobile phase pH (2.8–3.2)—to achieve maximum resolution, peak area, and analytical reproducibility. Chromatographic separation was performed on a Kromasil C18 column using ethanol and 0.1 % TFA (50:50, v/v) as the mobile phase. Mass spectrometric detection employed selected reaction monitoring in positive ion mode using an LC-MS/MS instrument. The method exhibited excellent linearity (10–400 ng/mL), low limits of detection (LOD: ∼3 ng/mL), and quantification (LOQ: ∼9 ng/mL) for both analytes, with recovery rates > 93 % and %CVs < 15 %. Greenness and sustainability assessments using analytical GREEnness metric (AGREE), analytical GREEnness metric for sample PREParation (AGREEprep), complementary green analytical procedure index (ComplexGAPI), Eco-Scale, and Blue applicability grade index (BAGI) confirmed the method’s environmental compatibility and analytical reliability, with scores exceeding 65 across all tools. This validated method demonstrates high sensitivity, reproducibility, and environmental responsibility, rendering it suitable for routine bioanalytical and pharmacokinetic applications.
{"title":"A green and robust LC–MS/MS bioanalytical method for sulopenem etzadroxil and probenecid: Optimization, validation, and pharmacokinetic application","authors":"Niloufer Tasnim Khazi, Kumaraswamy Gandla, Lalitha Repudi","doi":"10.1016/j.jpbao.2025.100083","DOIUrl":"10.1016/j.jpbao.2025.100083","url":null,"abstract":"<div><div>A novel, green, and robust Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed and validated for the simultaneous quantification of sulopenem etzadroxil and probenecid in rat plasma, with application to pharmacokinetic studies. Method development was guided by a Box–Behnken Design and response surface methodology, optimizing key chromatographic variables—ethanol proportion (40–60 %), flow rate (0.8–1.2 mL/min), and mobile phase pH (2.8–3.2)—to achieve maximum resolution, peak area, and analytical reproducibility. Chromatographic separation was performed on a Kromasil C18 column using ethanol and 0.1 % TFA (50:50, v/v) as the mobile phase. Mass spectrometric detection employed selected reaction monitoring in positive ion mode using an LC-MS/MS instrument. The method exhibited excellent linearity (10–400 ng/mL), low limits of detection (LOD: ∼3 ng/mL), and quantification (LOQ: ∼9 ng/mL) for both analytes, with recovery rates > 93 % and %CVs < 15 %. Greenness and sustainability assessments using analytical GREEnness metric (AGREE), analytical GREEnness metric for sample PREParation (AGREEprep), complementary green analytical procedure index (ComplexGAPI), Eco-Scale, and Blue applicability grade index (BAGI) confirmed the method’s environmental compatibility and analytical reliability, with scores exceeding 65 across all tools. This validated method demonstrates high sensitivity, reproducibility, and environmental responsibility, rendering it suitable for routine bioanalytical and pharmacokinetic applications.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100083"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-04DOI: 10.1016/j.jpbao.2025.100095
Prajna Gupta , Saurav Sarkar , Sandip Karmakar , Sougata Jana , Gouranga Nandi , Sreejan Manna
The recent advancements in medical science and technology have enabled the diversified applications of existing drug delivery systems. Scaffolds are regarded as a relatively novel drug delivery system mostly employed in therapeutic and biomedical applications. In recent times, scaffolds are widely being investigated for sensory applications in in-vivo conditions. The mostly employed scaffold types for sensory applications are nanofibers, hydrogels, 3-D printed scaffolds and microparticulate scaffolds. Owing to its favorable physicochemical properties, scaffolds can also simultaneously function as a sensor in biological environment and also as delivery vectors. The surface charge, optical properties, porous nature, higher mechanical strength, and biodegradable behavior of polymeric scaffolds have encouraged pharmaceutical researchers to investigate upon it as biosensor. The ease of fabrication techniques, compatibility for customization and functionalization have made scaffolds a versatile system that is yet to be fully explored. The connection for integration of biosensor within scaffold has been described in this article. This review outlines the suitability of biomaterials-based scaffolds in sensory applications alongside the commonly employed fabrication techniques and biosensing applications.
{"title":"Biosensory implications of scaffolds: Designing, integration and biomedical applications","authors":"Prajna Gupta , Saurav Sarkar , Sandip Karmakar , Sougata Jana , Gouranga Nandi , Sreejan Manna","doi":"10.1016/j.jpbao.2025.100095","DOIUrl":"10.1016/j.jpbao.2025.100095","url":null,"abstract":"<div><div>The recent advancements in medical science and technology have enabled the diversified applications of existing drug delivery systems. Scaffolds are regarded as a relatively novel drug delivery system mostly employed in therapeutic and biomedical applications. In recent times, scaffolds are widely being investigated for sensory applications in in-vivo conditions. The mostly employed scaffold types for sensory applications are nanofibers, hydrogels, 3-D printed scaffolds and microparticulate scaffolds. Owing to its favorable physicochemical properties, scaffolds can also simultaneously function as a sensor in biological environment and also as delivery vectors. The surface charge, optical properties, porous nature, higher mechanical strength, and biodegradable behavior of polymeric scaffolds have encouraged pharmaceutical researchers to investigate upon it as biosensor. The ease of fabrication techniques, compatibility for customization and functionalization have made scaffolds a versatile system that is yet to be fully explored. The connection for integration of biosensor within scaffold has been described in this article. This review outlines the suitability of biomaterials-based scaffolds in sensory applications alongside the commonly employed fabrication techniques and biosensing applications.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100095"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-09-16DOI: 10.1016/j.jpbao.2025.100089
Erika Maria Ricci , Miryam Perrucci , Marcello Locatelli , Imran Ali , Halil I. Ulusoy , Abuzar Kabir , Fotouh R. Mansour
Growing concerns over environmental pollution have led to increased emphasis on Green Chemistry and, more specifically, Green Analytical Chemistry (GAC). These frameworks advocate for the reduction of hazardous substances, minimization of waste, and consideration of the entire life cycle of analytical procedures—from production to disposal. Within this context, miniaturized analytical techniques have emerged as sustainable and efficient alternatives to conventional methods. Among these, capillary liquid chromatography (cLC), nano-liquid chromatography (nano-LC), and various modes of capillary electrophoresis (CE)—including micellar electrokinetic chromatography (MEKC), capillary isotachophoresis (CITP), capillary zone electrophoresis (CZE), capillary isoelectric focusing (CIEF), and capillary gel electrophoresis (CGE) have gained significant traction. Their advantages in terms of reduced solvent and sample consumption, enhanced resolution, and faster analysis times have made them particularly valuable in pharmaceutical and biomedical applications. One critical application area is the chiral separation of active pharmaceutical ingredients (APIs), which is increasingly vital in biotechnology, chemistry, agriculture, and especially the pharmaceutical industry. Electrokinetic chromatography (EKC) has proven to be an effective and versatile technique for this purpose, offering high resolution, flexibility, speed, and cost-efficiency. The growing availability of novel chiral selectors further enhances its appeal for the separation of enantiomeric drug compounds. This review provides an overview of recent advancements in miniaturized analytical techniques and highlights their applications in the biomedical and pharmaceutical sectors, with a particular focus on chiral separations using EKC.
{"title":"Miniaturization in action: High-resolution, low-cost analytical platforms for biomedical and pharmaceutical research","authors":"Erika Maria Ricci , Miryam Perrucci , Marcello Locatelli , Imran Ali , Halil I. Ulusoy , Abuzar Kabir , Fotouh R. Mansour","doi":"10.1016/j.jpbao.2025.100089","DOIUrl":"10.1016/j.jpbao.2025.100089","url":null,"abstract":"<div><div>Growing concerns over environmental pollution have led to increased emphasis on Green Chemistry and, more specifically, Green Analytical Chemistry (GAC). These frameworks advocate for the reduction of hazardous substances, minimization of waste, and consideration of the entire life cycle of analytical procedures—from production to disposal. Within this context, miniaturized analytical techniques have emerged as sustainable and efficient alternatives to conventional methods. Among these, capillary liquid chromatography (cLC), nano-liquid chromatography (nano-LC), and various modes of capillary electrophoresis (CE)—including micellar electrokinetic chromatography (MEKC), capillary isotachophoresis (CITP), capillary zone electrophoresis (CZE), capillary isoelectric focusing (CIEF), and capillary gel electrophoresis (CGE) have gained significant traction. Their advantages in terms of reduced solvent and sample consumption, enhanced resolution, and faster analysis times have made them particularly valuable in pharmaceutical and biomedical applications. One critical application area is the chiral separation of active pharmaceutical ingredients (APIs), which is increasingly vital in biotechnology, chemistry, agriculture, and especially the pharmaceutical industry. Electrokinetic chromatography (EKC) has proven to be an effective and versatile technique for this purpose, offering high resolution, flexibility, speed, and cost-efficiency. The growing availability of novel chiral selectors further enhances its appeal for the separation of enantiomeric drug compounds. This review provides an overview of recent advancements in miniaturized analytical techniques and highlights their applications in the biomedical and pharmaceutical sectors, with a particular focus on chiral separations using EKC.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100089"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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