Chili pepper cultivars come in a broad variety of tastes, colors, sizes, and spiciness levels due to various growth conditions. The significance of different chili peppers and other spices in Thai cuisine may be seen in dishes. This study evaluated the nutritional composition and capsaicin content from “Bang Chang” Thai cultivar chili pepper after drying, and the inhibition of lipase, tyrosinase and elastase enzymes from its oil and ethanol extracts. The nutritional composition of sun-dried chili pepper was high dietary fiber and beta-carotene, which were significantly high amount portion of Thai recommended dietary intake (RDI). According to calculations and definitions, “Bang Chang chili pepper” is a non-pungent Capsicum (0-700 SHU) since it contains a low amount of capsaicin. Total phenolic content was more abundant in ethanol extract (2.50 ± 0.13 mg GAE/g) than oil extract (1.05 ± 0.05 mg GAE/g). Compared to the positive control orlistat (IC50 = 3.26 ± 0.28 mg/mL), an anti-lipase drug, ethanol extract was 2.0 times more lipase inhibitory. In addition, ethanol extract was mildly anti-tyrosinase, while oil extract was non-activity. The anti-lipase activity of ethanol extract was due to phenolic content rather than capsaicin contained and this enzyme inhibition may act on active site. We found that ethanol extract of “Bang Chang” cultivar chili pepper yielded higher TPC content and more effective anti-lipase than oil extract. The finding provided benefits on applying this chili pepper on anti-lipase use and weight management.
{"title":"Nutritional Composition, Capsaicin Content and Enzyme Inhibitory Activities from “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum) after Drying Process","authors":"Kanyapat Petcharaporn, Kanittada Thongkao, Pimporn Thongmuang, Yuttana Sudjaroen","doi":"10.25258/ijpqa.14.3.41","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.41","url":null,"abstract":"Chili pepper cultivars come in a broad variety of tastes, colors, sizes, and spiciness levels due to various growth conditions. The significance of different chili peppers and other spices in Thai cuisine may be seen in dishes. This study evaluated the nutritional composition and capsaicin content from “Bang Chang” Thai cultivar chili pepper after drying, and the inhibition of lipase, tyrosinase and elastase enzymes from its oil and ethanol extracts. The nutritional composition of sun-dried chili pepper was high dietary fiber and beta-carotene, which were significantly high amount portion of Thai recommended dietary intake (RDI). According to calculations and definitions, “Bang Chang chili pepper” is a non-pungent Capsicum (0-700 SHU) since it contains a low amount of capsaicin. Total phenolic content was more abundant in ethanol extract (2.50 ± 0.13 mg GAE/g) than oil extract (1.05 ± 0.05 mg GAE/g). Compared to the positive control orlistat (IC50 = 3.26 ± 0.28 mg/mL), an anti-lipase drug, ethanol extract was 2.0 times more lipase inhibitory. In addition, ethanol extract was mildly anti-tyrosinase, while oil extract was non-activity. The anti-lipase activity of ethanol extract was due to phenolic content rather than capsaicin contained and this enzyme inhibition may act on active site. We found that ethanol extract of “Bang Chang” cultivar chili pepper yielded higher TPC content and more effective anti-lipase than oil extract. The finding provided benefits on applying this chili pepper on anti-lipase use and weight management.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867457","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}
The primary purpose of this research was to create and validate a doxylamine detection method using reverse phase high performance liquid chromatography (RP-HPLC) for use in pharmaceutical formulations and bulk materials. Quality by design (QbD) served as the inspiration for this approach. The method was developed by running a C18 column at 1-mL/min through a mobile phase of 60 parts methanol to 40 parts 0.1% OPA water (pH 2.8). The detection was done with a UV detector set to 259 nm. All requirements for system applicability were satisfied by the suggested approach, including an acceptable asymmetry factor and an adequate number of theoretical plates. A correlation coefficient (R2) of 0.9990 was used to confirm linearity over a concentration of 10–50 g/mL. The approach showed good accuracy by a mean %recovery ranging from 99.59–101.45% and a %RSD between 0.11 and 0.81. Precision tests conducted both intraday and across days showed that the medication content stayed within allowable bounds. The approach was found to be robust, with only minor variations in flow rate, mobile phase composition, and detecting wavelength significantly affecting the accuracy and specificity. A 0.71 g/mL LoQ and a 0.23 g/mL LoD were determined to be analytical limits of detection and quantification, respectively. This study substantiates the development of a reliable, long-lasting, and cost-effective QbD-based RP-HPLC method suitable for the comprehensive analysis of doxylamine in tablet formulations and bulk dosage
{"title":"Application of Quality by Design in RP-HPLC for Robust Impurity Profiling and Stability Assessment of Doxylamine","authors":"Avinash Chavan, R Gandhimathi","doi":"10.25258/ijpqa.14.3.31","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.31","url":null,"abstract":"The primary purpose of this research was to create and validate a doxylamine detection method using reverse phase high performance liquid chromatography (RP-HPLC) for use in pharmaceutical formulations and bulk materials. Quality by design (QbD) served as the inspiration for this approach. The method was developed by running a C18 column at 1-mL/min through a mobile phase of 60 parts methanol to 40 parts 0.1% OPA water (pH 2.8). The detection was done with a UV detector set to 259 nm. All requirements for system applicability were satisfied by the suggested approach, including an acceptable asymmetry factor and an adequate number of theoretical plates. A correlation coefficient (R2) of 0.9990 was used to confirm linearity over a concentration of 10–50 g/mL. The approach showed good accuracy by a mean %recovery ranging from 99.59–101.45% and a %RSD between 0.11 and 0.81. Precision tests conducted both intraday and across days showed that the medication content stayed within allowable bounds. The approach was found to be robust, with only minor variations in flow rate, mobile phase composition, and detecting wavelength significantly affecting the accuracy and specificity. A 0.71 g/mL LoQ and a 0.23 g/mL LoD were determined to be analytical limits of detection and quantification, respectively. This study substantiates the development of a reliable, long-lasting, and cost-effective QbD-based RP-HPLC method suitable for the comprehensive analysis of doxylamine in tablet formulations and bulk dosage","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867462","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 specific, linear and precise liquid chromatographic-tandem mass spectrometric method was established and validated for the quantitation of orlistat in sample plasma. Zorbax C18 (4.6 mm i.d.× 50.0 mm; 5.0 μm) stationary phase was utilized to achieve chromatography elution, through a flowing rate of 0.90 mL/min. Isocratic elution was done using methanol, acetonitrile and 0.10% v/v HCOOH in a fraction of 80:10: 10 v/v/v as the mobile phasic system. For drug and internal standard separation, the precipitation extraction technique used acetonitrile as solvent. A triple quadrupole mass detector was employed for the quantification of ions. Electrospray ionization in a positive ionizing method, which was executed in multiple reaction monitorings (MRM) with parent/product ion transitions of m/z 496.4→337.31 for orlistat and 506.23→57.07 for amprenavir internal standard. The calibration graph was executed between the concentrations of 4.75–190.0 ng/mL and the resulting equation was y = 0.0058x + 0.0022 with r2 value of more than 0.99. Orlistat recovery values were found to be more than 93.65%, and its accuracy, measured in relative error, was in the range of -4.48 to 3.49%. Accuracy findings, sensitivity and recovery values of orlistat in the sample plasma for the established technique evidences its importance in pharmacokinetic and bioequivalence study.
{"title":"Liquid Chromatography Tandem Mass Spectrometric Method Development and Validation for the Quantification of Orlistat in Biological Matrices","authors":"K.V Sundaram, D.V.R.N Bhikshapathi","doi":"10.25258/ijpqa.14.3.37","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.37","url":null,"abstract":"A specific, linear and precise liquid chromatographic-tandem mass spectrometric method was established and validated for the quantitation of orlistat in sample plasma. Zorbax C18 (4.6 mm i.d.× 50.0 mm; 5.0 μm) stationary phase was utilized to achieve chromatography elution, through a flowing rate of 0.90 mL/min. Isocratic elution was done using methanol, acetonitrile and 0.10% v/v HCOOH in a fraction of 80:10: 10 v/v/v as the mobile phasic system. For drug and internal standard separation, the precipitation extraction technique used acetonitrile as solvent. A triple quadrupole mass detector was employed for the quantification of ions. Electrospray ionization in a positive ionizing method, which was executed in multiple reaction monitorings (MRM) with parent/product ion transitions of m/z 496.4→337.31 for orlistat and 506.23→57.07 for amprenavir internal standard. The calibration graph was executed between the concentrations of 4.75–190.0 ng/mL and the resulting equation was y = 0.0058x + 0.0022 with r2 value of more than 0.99. Orlistat recovery values were found to be more than 93.65%, and its accuracy, measured in relative error, was in the range of -4.48 to 3.49%. Accuracy findings, sensitivity and recovery values of orlistat in the sample plasma for the established technique evidences its importance in pharmacokinetic and bioequivalence study.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867470","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}
Objectives: This research aimed to explore the therapeutic potential of Sedum lineare Thunb by conducting phytochemical analysis and identifying active bioactive compounds. Materials and Methods: S. lineare Thunb samples were collected from Pune district, Maharashtra, India in December 2022. Preparation of extracts using a hydroalcoholic solvent (ethanol: water, 70:30 v/v). Phytochemical screening using established methods to determine the presence of alkaloids, flavonoids, glycosides, diterpenes, carbohydrates, saponins, and tannins. Quantitative determination of total phenol and flavonoid contents in the hydroalcoholic extract. Identification of the marker compound (quercetin) in the S. lineare Thunb extract using HPLC. Results and Discussion: Alkaloids, glycosides, flavonoids, diterpenes, carbohydrates, saponins, and tannins were all found in the crude extracts by phytochemical analysis. The hydroalcoholic extract exhibited total phenol and flavonoid contents of 2.75 and 1.452 mg/100 mg, respectively. Quantitative estimation of quercetin in the hydroalcoholic extract was determined to be 0.0148%. Conclusion: The study demonstrated that S. lineare Thunb extracts contain various secondary metabolites, including phenolic compounds, flavonoids, and other bioactive compounds. The hydroalcoholic extract showed significant total phenol and flavonoid contents, indicating its potential therapeutic value. Further research is warranted to explore the specific health benefits and therapeutic applications of the identified bioactive compounds in S. lineare Thunb
{"title":"Exploring the Therapeutic Potential of Sedum lineare Thunb: Phytochemical Analysis and Identification of Active Bioactive Compounds","authors":"Sunil Kumar, A.K.S Rawat, Akash Ved, Peeyush Bhardwaj","doi":"10.25258/ijpqa.14.3.43","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.43","url":null,"abstract":"Objectives: This research aimed to explore the therapeutic potential of Sedum lineare Thunb by conducting phytochemical analysis and identifying active bioactive compounds. Materials and Methods: S. lineare Thunb samples were collected from Pune district, Maharashtra, India in December 2022. Preparation of extracts using a hydroalcoholic solvent (ethanol: water, 70:30 v/v). Phytochemical screening using established methods to determine the presence of alkaloids, flavonoids, glycosides, diterpenes, carbohydrates, saponins, and tannins. Quantitative determination of total phenol and flavonoid contents in the hydroalcoholic extract. Identification of the marker compound (quercetin) in the S. lineare Thunb extract using HPLC. Results and Discussion: Alkaloids, glycosides, flavonoids, diterpenes, carbohydrates, saponins, and tannins were all found in the crude extracts by phytochemical analysis. The hydroalcoholic extract exhibited total phenol and flavonoid contents of 2.75 and 1.452 mg/100 mg, respectively. Quantitative estimation of quercetin in the hydroalcoholic extract was determined to be 0.0148%. Conclusion: The study demonstrated that S. lineare Thunb extracts contain various secondary metabolites, including phenolic compounds, flavonoids, and other bioactive compounds. The hydroalcoholic extract showed significant total phenol and flavonoid contents, indicating its potential therapeutic value. Further research is warranted to explore the specific health benefits and therapeutic applications of the identified bioactive compounds in S. lineare Thunb","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867474","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}
Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.
{"title":"A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application","authors":"Avinash Chavan, R Gandhimathi","doi":"10.25258/ijpqa.14.3.40","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.40","url":null,"abstract":"Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867689","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}
Aim of study: To investigate the effects of antipsychotic medications utilized to treat schizophrenic patients and its effects on the reproductive system. Introduction: Antipsychotics, anticonvulsants, and other all psychotropic drugs have negative effects on the quality of sperm and sexual activity. These negative side effects differ amongst males and its less severe for some drugs, enabling some degree of control over their effects. Sperm can suffer oxidative damage from spending too much time in the male reproductive system. One of the antipsychotics most frequently administered to treat schizophrenia in adults is quetiapine. In this work, the effects of repeated rats’ healthy production of sperm in response to therapeutic doses of quetiapine was studied. Rats were also used to assess quetiapine’s effects on hormonal balance and oxidative state. Methodology: The experiment employed male wistar rats weighing 300 to 350 g at 10 to 12 weeks of age. The experiment employed male wistar rats weighing 300 to 350 g at 10 to 12 weeks of age. Rats received oral dosages of quetiapine for 30 days. At this time’s conclusion, the body’s weights and the organs were analyzed, additionally to sperm concentration, motility, shape, and degree of sperm damage. The levels of testosterone, LH, and other male hormones related to reproduction were measured in the serum. Malondialdehyde and glutathione levels were measured to assess the oxidative state of testicular tissues. Results: The results of this investigation demonstrated that in rats receiving quetiapine, aberrant sperm morphology increased while relative epididymis weights and sperm concentration dropped. Rats receiving quetiapine experienced a drop in serum LH and testosterone levels. Rats receiving quetiapine also had lower amounts of malondialdehyde, which was assessed. Conclusion: Quetiapine therapy this negative effect may be attributed to lower sperm quality, changed hormone levels, and enhanced oxidative stress.
{"title":"A Stability Indicating RP-HPLC Method for the Estimation of Nebivolol Hydrochloride in Human Plasma","authors":"Kaveri T Vaditake, Atul A Shirkhedkar","doi":"10.25258/ijpqa.14.3.11","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.11","url":null,"abstract":"Aim of study: To investigate the effects of antipsychotic medications utilized to treat schizophrenic patients and its effects on the reproductive system. Introduction: Antipsychotics, anticonvulsants, and other all psychotropic drugs have negative effects on the quality of sperm and sexual activity. These negative side effects differ amongst males and its less severe for some drugs, enabling some degree of control over their effects. Sperm can suffer oxidative damage from spending too much time in the male reproductive system. One of the antipsychotics most frequently administered to treat schizophrenia in adults is quetiapine. In this work, the effects of repeated rats’ healthy production of sperm in response to therapeutic doses of quetiapine was studied. Rats were also used to assess quetiapine’s effects on hormonal balance and oxidative state. Methodology: The experiment employed male wistar rats weighing 300 to 350 g at 10 to 12 weeks of age. The experiment employed male wistar rats weighing 300 to 350 g at 10 to 12 weeks of age. Rats received oral dosages of quetiapine for 30 days. At this time’s conclusion, the body’s weights and the organs were analyzed, additionally to sperm concentration, motility, shape, and degree of sperm damage. The levels of testosterone, LH, and other male hormones related to reproduction were measured in the serum. Malondialdehyde and glutathione levels were measured to assess the oxidative state of testicular tissues. Results: The results of this investigation demonstrated that in rats receiving quetiapine, aberrant sperm morphology increased while relative epididymis weights and sperm concentration dropped. Rats receiving quetiapine experienced a drop in serum LH and testosterone levels. Rats receiving quetiapine also had lower amounts of malondialdehyde, which was assessed. Conclusion: Quetiapine therapy this negative effect may be attributed to lower sperm quality, changed hormone levels, and enhanced oxidative stress.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135866580","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}
This study used a quality-by-design (QbD) method to build a novel, high-performance reverse-phase fluid chromatography (RP-HPLC) system with diode array detection (DAD) for the simultaneous measurement of dolutegravir (DLG) and lamivudine (LMV) tablets. In accordance with the International Council for Harmonization’s (ICH) requirements, chromatographic conditions were adjusted utilizing the Box-Behnken design (BBD), and the resultant technique was verified for linearity, system appropriateness, precision, accuracy, sensitivity, robustness, and stability of the solution. At retention durations of 2,271 and 3,431 minutes, LMV and DLG peaks were separated using a C-18 column with 150 x 4.6 mm and 5 μm particles. The mobile phase was 0.1% orthophosphoric acid (OPA): acetonitrile (ACN) (50:50, v/v) at a flow rate of 0.8 mL/min and a pH of 3 at 25°C. Peaks were seen at 254 nm and the volume of sample injection was 20L. The percent strength of the commercially available tablet is 98.89 and 98.76 for LMV and DLG, respectively, using a standard calibration curve. The developed RP-HPLC technique’s stability is shown by the suggested RP-HPLC method’s capacity to identify LMV and DLG in the existence of their degradation products. As per ICH requirements, the findings of the validation parameters for linearity, system appropriateness, accuracy, precision, robustness, and sensitivity were all within acceptable limits. It is simple to use, accurate, efficient, and reasonably priced to employ the innovative RP-HPLC technology with BBD application for QbD.
{"title":"An efficient RP-HPLC-PDA Method for Estimating Dolutegravir and Lamivudine in Combined Pharmaceutical Formulations using a Box-Behnken Design Approach","authors":"A. Ramyasree, S. Umadevi","doi":"10.25258/ijpqa.14.3.08","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.08","url":null,"abstract":"This study used a quality-by-design (QbD) method to build a novel, high-performance reverse-phase fluid chromatography (RP-HPLC) system with diode array detection (DAD) for the simultaneous measurement of dolutegravir (DLG) and lamivudine (LMV) tablets. In accordance with the International Council for Harmonization’s (ICH) requirements, chromatographic conditions were adjusted utilizing the Box-Behnken design (BBD), and the resultant technique was verified for linearity, system appropriateness, precision, accuracy, sensitivity, robustness, and stability of the solution. At retention durations of 2,271 and 3,431 minutes, LMV and DLG peaks were separated using a C-18 column with 150 x 4.6 mm and 5 μm particles. The mobile phase was 0.1% orthophosphoric acid (OPA): acetonitrile (ACN) (50:50, v/v) at a flow rate of 0.8 mL/min and a pH of 3 at 25°C. Peaks were seen at 254 nm and the volume of sample injection was 20L. The percent strength of the commercially available tablet is 98.89 and 98.76 for LMV and DLG, respectively, using a standard calibration curve. The developed RP-HPLC technique’s stability is shown by the suggested RP-HPLC method’s capacity to identify LMV and DLG in the existence of their degradation products. As per ICH requirements, the findings of the validation parameters for linearity, system appropriateness, accuracy, precision, robustness, and sensitivity were all within acceptable limits. It is simple to use, accurate, efficient, and reasonably priced to employ the innovative RP-HPLC technology with BBD application for QbD.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867449","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}
Objective: To assess the pattern and prevalence of adverse drug reactions (ADRs) reported by the neurology department and review the benefits of the pharmaceutical care plan. Materials and Methods: A total of 148 stroke cases with previous medication history correlated with current complaints leading to hospitalization were included in the prospective study for one year in the neurology department. Results: This study identified non-adherence (50%) and ADRs (38%). Ignorance of the disease, its complications, and the possible adverse effects of self-medication have been identified as risk factors. The medication-related problems were mainly observed with antimicrobials, central nervous system (CNS), central venous system (CVS), and inflammatory and immune modulators. Conclusion: The risk factors involved are illiteracy regarding prescribed therapy benefits. In the patient’s medication therapy, warfarin has more adverse events, and an observation of the patient’s plasma concentration levels increased.
{"title":"The Implementation and Evaluation of Pharmaceutical Care Plan in Stroke Patients at Tertiary Care Hospital","authors":"Dharani Gopu, Akila Devi D","doi":"10.25258/ijpqa.14.3.28","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.28","url":null,"abstract":"Objective: To assess the pattern and prevalence of adverse drug reactions (ADRs) reported by the neurology department and review the benefits of the pharmaceutical care plan. Materials and Methods: A total of 148 stroke cases with previous medication history correlated with current complaints leading to hospitalization were included in the prospective study for one year in the neurology department. Results: This study identified non-adherence (50%) and ADRs (38%). Ignorance of the disease, its complications, and the possible adverse effects of self-medication have been identified as risk factors. The medication-related problems were mainly observed with antimicrobials, central nervous system (CNS), central venous system (CVS), and inflammatory and immune modulators. Conclusion: The risk factors involved are illiteracy regarding prescribed therapy benefits. In the patient’s medication therapy, warfarin has more adverse events, and an observation of the patient’s plasma concentration levels increased.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"42 3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867460","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}
Dasatinib is one of the second-generation tyrosine kinase inhibitors (TKI) that is taken orally and has antiproliferative activity against chronic myeloid leukemia (CML). Dasatinib/hesperidin loaded-SLNs were synthesized in-house using a high-shear homogenizer and optimized by central composite design (CCD). Oral bioavailability and in-vivo anti-leukemic potential of developed dasatinib/hesperidin-loaded-solid lipid nanoparticles (SLNs) were determined using intravenous injection of leukemia cells in mice model. Dasatinib was administered as pure drug (suspension) and SLN formulation in leukemic mice modal. The pharmacokinetic profile was studied and compared with drug suspension using HPLC. Results denoted mean maximum plasma concentrations Cmax as 184.52 and 390.43 ng/mL, mean Tmax as 2 and 4 hours, mean half-life as 4.63 and 8.06 hours., for pure drug (suspension) and SLN formulation, respectively. The mean area under the curve (AUClast) was 1080.94 and 3669.49 hr*ng/mL for the same. SLN also showed statistically significant survival. A comparison of SLN and free drugs revealed that SLN was more effective at cytotoxicity. Therefore, the developed dual-targeted SLN formulation of dasatinib demonstrated higher sensitivity of cells to the drug entrapped in SLN than the drug suspension.
{"title":"Evaluation of Oral Bioavailability and In-vivo Anti-leukemic Potential of Dasatinib Loaded Solid Lipid Nanoparticles","authors":"Moinuddin ., Sachin Neekhra, Saeem Ahmad, SK Swarnkar, Deepa Gupta, Alok Khunteta, Pankaj Jain, Sonika Jain","doi":"10.25258/ijpqa.14.3.21","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.21","url":null,"abstract":"Dasatinib is one of the second-generation tyrosine kinase inhibitors (TKI) that is taken orally and has antiproliferative activity against chronic myeloid leukemia (CML). Dasatinib/hesperidin loaded-SLNs were synthesized in-house using a high-shear homogenizer and optimized by central composite design (CCD). Oral bioavailability and in-vivo anti-leukemic potential of developed dasatinib/hesperidin-loaded-solid lipid nanoparticles (SLNs) were determined using intravenous injection of leukemia cells in mice model. Dasatinib was administered as pure drug (suspension) and SLN formulation in leukemic mice modal. The pharmacokinetic profile was studied and compared with drug suspension using HPLC. Results denoted mean maximum plasma concentrations Cmax as 184.52 and 390.43 ng/mL, mean Tmax as 2 and 4 hours, mean half-life as 4.63 and 8.06 hours., for pure drug (suspension) and SLN formulation, respectively. The mean area under the curve (AUClast) was 1080.94 and 3669.49 hr*ng/mL for the same. SLN also showed statistically significant survival. A comparison of SLN and free drugs revealed that SLN was more effective at cytotoxicity. Therefore, the developed dual-targeted SLN formulation of dasatinib demonstrated higher sensitivity of cells to the drug entrapped in SLN than the drug suspension.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"77 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867472","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}
Background: Despite the availability of numerous treatment options, cancer remains the primary cause of death in the current decade. The present study integrates computational and experimental methods to identify and develop a novel promising compound with anticancer properties. The study aims to evaluate the potential anticancer properties of selected molecules based on docking score, compliance with Lipinski’s rule of five, and in-silico safety prediction. Structure drug design by molecular docking methods was used to explore ligand conformations at various target binding sites. The in-silico physicochemical, pharmacokinetic, and toxicology properties of designed molecules were predicted using online software. Further, in-vitro, anticancer properties were studied by MTT Assay and flow cytometry. Results: 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran is one of the selected ligands showed potent anticancer activity against HT- 29 (Human Colon Cancer) cells and A549 (Human lung cancer) at IC50 concentrations. Further apoptosis studies demonstrated the possible mode of action against HT-29 cells. The proposed mechanism of action may be caspase-3 activation. As a consequence of caspase-3 activation, enzymes such as DNase are activated, leading to DNA fragmentation and apoptosis, and DNA fragmentation was 6.5 times greater than in untreated cells. The IC50 concentration of 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran inhibited 50% of HT-29 cells during G0/G1 phase. Conclusion: This research contributes to the burgeoning field of integrated in-vitro and in-silico analysis of biological systems, which can be used to study complicated cancer cell population dynamics. Future studies should investigate the impact on Human lung cancer cells.
背景:尽管有许多治疗选择，癌症仍然是当前十年的主要死亡原因。本研究结合计算和实验方法来鉴定和开发一种具有抗癌特性的新型有前途的化合物。该研究旨在基于对接评分、Lipinski 's rule of five的依从性和计算机安全性预测来评估选定分子的潜在抗癌特性。通过分子对接方法进行结构药物设计，探索不同靶标结合位点的配体构象。利用在线软件预测设计分子的物理化学、药代动力学和毒理学性质。此外，通过MTT实验和流式细胞术研究了其体外抗癌特性。结果:2-丁基-3-(3,5 -二碘-4-羟基苯甲酰基)苯并呋喃在IC50浓度下对HT- 29(人结肠癌)细胞和A549(人肺癌)细胞表现出较强的抗癌活性。进一步的细胞凋亡研究证实了其对HT-29细胞的可能作用模式。提出的作用机制可能是caspase-3激活。由于caspase-3的激活，DNA酶等酶被激活，导致DNA片段化和细胞凋亡，DNA片段化程度是未处理细胞的6.5倍。2-丁基-3-(3,5 -二碘-4-羟基苯甲酰基)苯并呋喃的IC50浓度在G0/G1期抑制50%的HT-29细胞。结论:本研究为生物系统的体外和计算机集成分析领域的发展做出了贡献，可用于研究复杂的癌细胞群体动态。未来的研究应该调查对人类肺癌细胞的影响。
{"title":"In-silico and In-vitro Studies on Targeting Tumor Apoptosis by Activating Caspase-3","authors":"Akula Sowjanya, G.Shiva Kumar","doi":"10.25258/ijpqa.14.3.34","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.34","url":null,"abstract":"Background: Despite the availability of numerous treatment options, cancer remains the primary cause of death in the current decade. The present study integrates computational and experimental methods to identify and develop a novel promising compound with anticancer properties. The study aims to evaluate the potential anticancer properties of selected molecules based on docking score, compliance with Lipinski’s rule of five, and in-silico safety prediction. Structure drug design by molecular docking methods was used to explore ligand conformations at various target binding sites. The in-silico physicochemical, pharmacokinetic, and toxicology properties of designed molecules were predicted using online software. Further, in-vitro, anticancer properties were studied by MTT Assay and flow cytometry. Results: 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran is one of the selected ligands showed potent anticancer activity against HT- 29 (Human Colon Cancer) cells and A549 (Human lung cancer) at IC50 concentrations. Further apoptosis studies demonstrated the possible mode of action against HT-29 cells. The proposed mechanism of action may be caspase-3 activation. As a consequence of caspase-3 activation, enzymes such as DNase are activated, leading to DNA fragmentation and apoptosis, and DNA fragmentation was 6.5 times greater than in untreated cells. The IC50 concentration of 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran inhibited 50% of HT-29 cells during G0/G1 phase. Conclusion: This research contributes to the burgeoning field of integrated in-vitro and in-silico analysis of biological systems, which can be used to study complicated cancer cell population dynamics. Future studies should investigate the impact on Human lung cancer cells.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867475","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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