Diabetes might be cured with the use of medicinal herbs and environmentally friendly production of metallic nanoparticles (Ag NPs) and ZnO NPs. The methanolic leaf extracts of Alpinia mutica and Tradescantia spathaeca were used to synthesize silver nanoparticles (Ag NPs) and zinc oxide nanoparticles (ZnO NPs), respectively, for in-vitro evaluation. Methanolic leaf extracts of A. mutica and T. spathaeca were used to create AgNPs and ZnO NPs under ambient conditions using ultrasound-assisted extraction (UAE). Their ability to block alpha- and beta-amylase confirmed the in-vitro antidiabetic efficacy of methanolic leaf extract of plant (MLEP), AgNPs, and ZnO NPs. In this study, α- amylase activity of ZnO and nanoparticles of silver produced from natural sources will be evaluated in an effort to lessen the toxicity and negative effects of the inhibitor used to treat diabetes. Antidiabetic action was especially impressive in the ZnO and silver nanoparticles produced using methanolic extracts of A. mutica and T. spathaeca. Because of their promising in-vitro antidiabetic action with alpha-amylase activity, MLEP of A. mutica and T. spathaeca, AgNPs, and ZnO NPs show promise for future medical uses.
{"title":"Exploration of In-vitro Antidiabetic Activity of ZnO NPs and Ag NPs Synthesized using Methanolic Extracts of Alpinia mutica and Tradescantia spathaeca Leaves","authors":"Shankaraiah Pulipaka, Ashish Suttee, M.Ravi Kumar, Ramesh Kasarla","doi":"10.25258/ijpqa.14.3.01","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.01","url":null,"abstract":"Diabetes might be cured with the use of medicinal herbs and environmentally friendly production of metallic nanoparticles (Ag NPs) and ZnO NPs. The methanolic leaf extracts of Alpinia mutica and Tradescantia spathaeca were used to synthesize silver nanoparticles (Ag NPs) and zinc oxide nanoparticles (ZnO NPs), respectively, for in-vitro evaluation. Methanolic leaf extracts of A. mutica and T. spathaeca were used to create AgNPs and ZnO NPs under ambient conditions using ultrasound-assisted extraction (UAE). Their ability to block alpha- and beta-amylase confirmed the in-vitro antidiabetic efficacy of methanolic leaf extract of plant (MLEP), AgNPs, and ZnO NPs. In this study, α- amylase activity of ZnO and nanoparticles of silver produced from natural sources will be evaluated in an effort to lessen the toxicity and negative effects of the inhibitor used to treat diabetes. Antidiabetic action was especially impressive in the ZnO and silver nanoparticles produced using methanolic extracts of A. mutica and T. spathaeca. Because of their promising in-vitro antidiabetic action with alpha-amylase activity, MLEP of A. mutica and T. spathaeca, AgNPs, and ZnO NPs show promise for future medical uses.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"26 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":"135867464","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 improper disposal of pharmaceutical waste has become an increasingly important environmental and public health concern in recent years. Pharmaceutical waste includes unused, expired, or unwanted medications that can be harmful if they end up in the environment or are improperly handled. This can include prescription drugs, over-the-counter medications, and veterinary drugs. Pharmaceutical waste can be generated by a variety of sources, including healthcare facilities, households, and veterinary clinics. Improper disposal of these medications can lead to water and soil contamination, as well as potential harm to wildlife and humans. In addition, pharmaceutical waste can contribute to the growing problem of antibiotic resistance and other environmental issues. To address these concerns, various disposal methods have been developed to ensure the safe and effective management of pharmaceutical waste. These methods include disposal in the trash, take-back programs, incineration, and landfill disposal. However, there is still a need for improved awareness and education on proper disposal practices among healthcare professionals, patients, and the general public. This review article aims to provide an overview of the current practices and regulations related to pharmaceutical waste disposal and the challenges and opportunities for improvement in this area. Through a comprehensive analysis of the existing literature on this topic, this article will highlight the importance of proper pharmaceutical waste disposal and the need for continued research and policy interventions to ensure a safe and sustainable approach. Our article highlights the importance of proper pharmaceutical waste disposal and the need for improved awareness and education on this topic among healthcare professionals, patients, and the general public.
{"title":"Pharmaceutical Waste Disposal Current Practices and Regulations: Review","authors":"Ingale M H, Tayade M C, Patil Y P, Salunkhe R H","doi":"10.25258/ijpqa.14.3.59","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.59","url":null,"abstract":"The improper disposal of pharmaceutical waste has become an increasingly important environmental and public health concern in recent years. Pharmaceutical waste includes unused, expired, or unwanted medications that can be harmful if they end up in the environment or are improperly handled. This can include prescription drugs, over-the-counter medications, and veterinary drugs. Pharmaceutical waste can be generated by a variety of sources, including healthcare facilities, households, and veterinary clinics. Improper disposal of these medications can lead to water and soil contamination, as well as potential harm to wildlife and humans. In addition, pharmaceutical waste can contribute to the growing problem of antibiotic resistance and other environmental issues. To address these concerns, various disposal methods have been developed to ensure the safe and effective management of pharmaceutical waste. These methods include disposal in the trash, take-back programs, incineration, and landfill disposal. However, there is still a need for improved awareness and education on proper disposal practices among healthcare professionals, patients, and the general public. This review article aims to provide an overview of the current practices and regulations related to pharmaceutical waste disposal and the challenges and opportunities for improvement in this area. Through a comprehensive analysis of the existing literature on this topic, this article will highlight the importance of proper pharmaceutical waste disposal and the need for continued research and policy interventions to ensure a safe and sustainable approach. Our article highlights the importance of proper pharmaceutical waste disposal and the need for improved awareness and education on this topic among healthcare professionals, patients, and the general public.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"5 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":"135867554","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: Studies reveal that the average age of stroke in less developed nations would be younger due to changing population structures brought on by increased mortality rates and other causes of death. The risk of death for AS patients is highest in the first few weeks and varies from 20 to 50% in the first month, depending on age, severity of stroke, other medical disorders, and treatment effectiveness for all outcomes. Furthermore, Tn subunits bind to muscle filaments, according to studies. Since it is a sensitive sign of myocardial necrosis, researchers have determined that it is widely used to diagnose acute coronary syndromes. Objective: To assess the link between serum TnI levels and AS in CAD cases. Methods: Based on the average patient volume and available resources at the KIMS, Karad from October 2017 to December 2019, our study comprised 57 patients. A structured and validated questionnaire was utilized to collect data. Microsoft Excel received the data. Tests were conducted using Epi-Info 7.2 and SPSS version 20. The student’s t-test is used to determine correlation, whereas the chi-square test was utilized to measure association. Result: A strong correlation was observed between mortality and elevated TnI levels in AS cases (p < 0.001). Conclusion: Patients with AIS showed significant TnI levels. Serum TnI levels were higher in patients with AIS, despite these levels being thought to be more selective for myocardial damage. TnI levels and AIS prognosis were substantially associated. The results of this study will improve our understanding of cardiac enzymes in AIS patients as well as how they impact prognosis.
背景:研究表明，由于死亡率增加和其他死亡原因导致的人口结构变化，欠发达国家中风的平均年龄将更年轻。AS患者的死亡风险在最初几周最高，在第一个月从20%到50%不等，这取决于年龄、中风的严重程度、其他医学疾病和所有结果的治疗效果。此外，根据研究，Tn亚基与肌肉细丝结合。由于它是心肌坏死的敏感信号，研究人员已经确定它被广泛用于诊断急性冠状动脉综合征。目的:探讨冠心病患者血清TnI水平与AS的关系。方法:基于2017年10月至2019年12月Karad KIMS的平均患者数量和可用资源，我们的研究纳入了57名患者。采用结构化和有效的问卷来收集数据。微软Excel接收数据。使用Epi-Info 7.2和SPSS version 20进行检验。学生t检验用于确定相关性，而卡方检验用于测量相关性。结果:AS患者的死亡率与TnI水平升高密切相关(p <0.001)。结论:AIS患者有明显的TnI水平。AIS患者的血清TnI水平更高，尽管这些水平被认为对心肌损伤更具选择性。TnI水平与AIS预后显著相关。本研究的结果将提高我们对AIS患者心脏酶的认识，以及它们如何影响预后。
{"title":"Correlation between Serum Troponin-I Levels and Acute Stroke in Coronary Artery Disease Patients","authors":"Shilpa Patil, Dilip Patil, Amit Porwal","doi":"10.25258/ijpqa.14.3.48","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.48","url":null,"abstract":"Background: Studies reveal that the average age of stroke in less developed nations would be younger due to changing population structures brought on by increased mortality rates and other causes of death. The risk of death for AS patients is highest in the first few weeks and varies from 20 to 50% in the first month, depending on age, severity of stroke, other medical disorders, and treatment effectiveness for all outcomes. Furthermore, Tn subunits bind to muscle filaments, according to studies. Since it is a sensitive sign of myocardial necrosis, researchers have determined that it is widely used to diagnose acute coronary syndromes. Objective: To assess the link between serum TnI levels and AS in CAD cases. Methods: Based on the average patient volume and available resources at the KIMS, Karad from October 2017 to December 2019, our study comprised 57 patients. A structured and validated questionnaire was utilized to collect data. Microsoft Excel received the data. Tests were conducted using Epi-Info 7.2 and SPSS version 20. The student’s t-test is used to determine correlation, whereas the chi-square test was utilized to measure association. Result: A strong correlation was observed between mortality and elevated TnI levels in AS cases (p < 0.001). Conclusion: Patients with AIS showed significant TnI levels. Serum TnI levels were higher in patients with AIS, despite these levels being thought to be more selective for myocardial damage. TnI levels and AIS prognosis were substantially associated. The results of this study will improve our understanding of cardiac enzymes in AIS patients as well as how they impact prognosis.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"26 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":"135867685","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}
Gnana R. Priya M, Lalchand D. Devhare, G. Dharmamoorthy, Mahendra V. Khairnar, R. Prasidha
Novel (2-anilino-N-(4,6-dimethyl-1,3-Benzosulfonazol-2-yl) ethanamide derivatives were synthesized and characterized by spectroscopy methods. All the compounds assessed for in-vitro antimicrobial activities on three strains are S. aureus, S. epidermis and E. coli by using disc plate method (25 μg/mL). Compounds 5a-5j showed good to excellent antimicrobial activity for three different strains compared to standard ciprofloxacin. Further screened by in-vitro cytotoxic activity against MCF-7 cell lines. Some compounds were 5i, 5c, 5b,5d and 5i showed high cytotoxic activities of IC50 values 73, 53,37,32 and 24 μg/mL, reference drug as Gefitinib against MCF-7 cell lines and MCF-12A. Further carried out docking studies using Schrodinger software to analyze the orientations, interactions and binding modes of these derivatives at the adenine -5-triphosphate binding site of EGFR (PDB ID: 2ITY), which indicated that the ligands show good interactions with active site residues in this structural benzothiazole class, and are considered lead compounds for further development as anti-breast cancer drugs
合成了新的(2-苯胺- n -(4,6-二甲基-1,3-苯并磺唑-2-基)乙酰胺衍生物，并用光谱方法对其进行了表征。膜片法测定化合物对金黄色葡萄球菌、表皮葡萄球菌和大肠杆菌的体外抑菌活性(25 μg/mL)。与标准环丙沙星相比，化合物5a-5j对3种不同菌株表现出良好至优异的抑菌活性。进一步筛选体外对MCF-7细胞系的细胞毒活性。其中5i、5c、5b、5d和5i的IC50值分别为73、53、37、32和24 μg/mL，对照药物为吉非替尼，对MCF-7细胞株和MCF-12A具有较高的细胞毒活性。进一步利用薛定谔软件进行对接研究，分析了这些衍生物在EGFR腺嘌呤-5-三磷酸结合位点(PDB ID: 2ITY)的取向、相互作用和结合方式，结果表明这些配体与这类结构苯并噻唑类活性位点残基具有良好的相互作用，是进一步开发抗乳腺癌药物的先导化合物
{"title":"Synthesis, Characterisation, Molecular Docking Studies and Biological Evaluation of Novel Benzothiazole Derivatives as EGFR Inhibitors for Anti-breast Cancer Agents","authors":"Gnana R. Priya M, Lalchand D. Devhare, G. Dharmamoorthy, Mahendra V. Khairnar, R. Prasidha","doi":"10.25258/ijpqa.14.3.03","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.03","url":null,"abstract":"Novel (2-anilino-N-(4,6-dimethyl-1,3-Benzosulfonazol-2-yl) ethanamide derivatives were synthesized and characterized by spectroscopy methods. All the compounds assessed for in-vitro antimicrobial activities on three strains are S. aureus, S. epidermis and E. coli by using disc plate method (25 μg/mL). Compounds 5a-5j showed good to excellent antimicrobial activity for three different strains compared to standard ciprofloxacin. Further screened by in-vitro cytotoxic activity against MCF-7 cell lines. Some compounds were 5i, 5c, 5b,5d and 5i showed high cytotoxic activities of IC50 values 73, 53,37,32 and 24 μg/mL, reference drug as Gefitinib against MCF-7 cell lines and MCF-12A. Further carried out docking studies using Schrodinger software to analyze the orientations, interactions and binding modes of these derivatives at the adenine -5-triphosphate binding site of EGFR (PDB ID: 2ITY), which indicated that the ligands show good interactions with active site residues in this structural benzothiazole class, and are considered lead compounds for further development as anti-breast cancer drugs","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":"135867770","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 goal of present study is to validate the developed assay method per International Council for Harmonisation (ICH) Q2R1 recommendations and create a sensitive, reproducible, and practical method for detecting curcumin and Vitamin E in pure and in cosmeceutical formulations. With the creation and validation of a straightforward, accurate, and repeatable UV spectrophotometric method, curcumin and vitamin E in bulk and cosmeceutical formulation may now be determined simultaneously. The need for a new technique to estimate curcumin and vitamin E in a cosmeceutical formulation has become more pressing due to the lack of a well-described UV analytical method for doing so. Q absorption at 231 and 285 nm were used in the calculation. Vitamin E (16–24 μg/mL) and curcumin (8–12 μg/mL) both behave according to Beer-Lambert’s law at the designated wavelengths. The recovery experiments verified the method’s adherence to ICH standards for accuracy, precision, and resilience. The method under consideration can be employed to accurately determine the quantities of vitamin E and curcumin present in a cosmeceutical formulation
{"title":"Simultaneous Estimation of Curcumin and Vitamin E in Bulk and Cosmeceutical Formulation by UV Spectrophotometry","authors":"Shilpa R. Borate, Atishkumar S. Mundada","doi":"10.25258/ijpqa.14.3.30","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.30","url":null,"abstract":"The goal of present study is to validate the developed assay method per International Council for Harmonisation (ICH) Q2R1 recommendations and create a sensitive, reproducible, and practical method for detecting curcumin and Vitamin E in pure and in cosmeceutical formulations. With the creation and validation of a straightforward, accurate, and repeatable UV spectrophotometric method, curcumin and vitamin E in bulk and cosmeceutical formulation may now be determined simultaneously. The need for a new technique to estimate curcumin and vitamin E in a cosmeceutical formulation has become more pressing due to the lack of a well-described UV analytical method for doing so. Q absorption at 231 and 285 nm were used in the calculation. Vitamin E (16–24 μg/mL) and curcumin (8–12 μg/mL) both behave according to Beer-Lambert’s law at the designated wavelengths. The recovery experiments verified the method’s adherence to ICH standards for accuracy, precision, and resilience. The method under consideration can be employed to accurately determine the quantities of vitamin E and curcumin present in a cosmeceutical formulation","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"70 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":"135866867","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}
There is a lack of data on dentists’ prescribing behaviors when it comes to the correct use of antibiotics in dental treatments. Antibiotic prescriptions made by dentists were analyzed from a diagnostic perspective in a countrywide study. This study retrospectively examined national health data from January 2018 through August 2019, collected through the Prescription Information System. The analysis only included prescriptions for a single illness and at least one systemic antibiotic. Antibiotic prescribing practices and the role of dental specialization and diagnosis were studied. A total of 9,214,956 prescriptions out of 9,293,410 matched the criteria for inclusion. An average course of antibiotic treatment consists of 1.01 pills. Antibiotics were prescribed most frequently for dental caries (16.2% of cases), dental examinations (20.7% of cases), and periapical abscess without sinuses (28.1% of cases). Antibiotics were prescribed for 96.6% of patients for illogical or confusing reasons, whereas just 3.4% were given based on a single, unambiguous diagnosis, such as cellulitis or a mouth abscess. The most commonly prescribed treatment for any medical issue was amoxicillin combined with an enzyme inhibitor (58.6%). Compared to unidentified dental practitioners (58.2%; p = 0.0001), dental specialists in Groups A and B significantly overprescribed amoxicillin plus an enzyme inhibitor (67.0 and 67.8%, respectively; p = 0.0001) (data not shown). The results of the study suggest that dentists routinely and arbitrarily prescribe antibiotics with questionable rationale in the contexts studied. These results emphasize the need for dentists to begin prescribing antibiotics more deliberately and evidence-based. Educational programs, awareness campaigns, and antibiotic stewardship programmes are just some of the interventions that may be implemented to improve prescribing practices and ensure the correct use of antibiotics in dental operations. The results of this countrywide study highlight problems with dentists’ procedures for prescribing dental antibiotics. The paper states that dentists should base their prescription practices on sound reasoning and empirical data. Dentists can help with global efforts to lower antibiotic resistance and improve patient care if they prescribe them in a more reasonable and responsible manner.
{"title":"Assessment of Prescription Patterns and Appropriateness of Antibiotics for Prophylaxis in Dental Procedures: A Retrospective Study","authors":"Ashima Jakhar, Nitesh Dahiya, Amit Patil, Himmat Jaiswal, Sheetal Mali, Deepak Sharma","doi":"10.25258/ijpqa.14.3.45","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.45","url":null,"abstract":"There is a lack of data on dentists’ prescribing behaviors when it comes to the correct use of antibiotics in dental treatments. Antibiotic prescriptions made by dentists were analyzed from a diagnostic perspective in a countrywide study. This study retrospectively examined national health data from January 2018 through August 2019, collected through the Prescription Information System. The analysis only included prescriptions for a single illness and at least one systemic antibiotic. Antibiotic prescribing practices and the role of dental specialization and diagnosis were studied. A total of 9,214,956 prescriptions out of 9,293,410 matched the criteria for inclusion. An average course of antibiotic treatment consists of 1.01 pills. Antibiotics were prescribed most frequently for dental caries (16.2% of cases), dental examinations (20.7% of cases), and periapical abscess without sinuses (28.1% of cases). Antibiotics were prescribed for 96.6% of patients for illogical or confusing reasons, whereas just 3.4% were given based on a single, unambiguous diagnosis, such as cellulitis or a mouth abscess. The most commonly prescribed treatment for any medical issue was amoxicillin combined with an enzyme inhibitor (58.6%). Compared to unidentified dental practitioners (58.2%; p = 0.0001), dental specialists in Groups A and B significantly overprescribed amoxicillin plus an enzyme inhibitor (67.0 and 67.8%, respectively; p = 0.0001) (data not shown). The results of the study suggest that dentists routinely and arbitrarily prescribe antibiotics with questionable rationale in the contexts studied. These results emphasize the need for dentists to begin prescribing antibiotics more deliberately and evidence-based. Educational programs, awareness campaigns, and antibiotic stewardship programmes are just some of the interventions that may be implemented to improve prescribing practices and ensure the correct use of antibiotics in dental operations. The results of this countrywide study highlight problems with dentists’ procedures for prescribing dental antibiotics. The paper states that dentists should base their prescription practices on sound reasoning and empirical data. Dentists can help with global efforts to lower antibiotic resistance and improve patient care if they prescribe them in a more reasonable and responsible manner.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"36 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":"135867550","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 stability of bisoprolol in tablet and bulk form was developed and validated using chromatographic methods. The bisoprolol was exposed to oxidizing agents like hydrogen peroxide, heat (dry and wet) and photolytic conditions, acid, alkali, and water hydrolysis. However, considerable degradation was observed in acid, alkali, oxidative, and wet heat thermal conditions. The drug’s stability under photolytic and dry heat conditions was established. The drug and its degradation products were separated on ODS C-18 with the specification of (250 mm × 4.6 mm, 5 μm) and the mobile phase containing acetonitrile and phosphate buffer (20 mM, pH 8) (60:40, v/v). According to ICH Q2 (R1) all method validation parameters are verified. Determination of the active pharmaceutical ingredient was not interfered by excipients or degradation products. In the 6–14 μg/mL range, the response was shown to be linear. One degradation product’s LC-MS m/z values and fragmentation patterns matched an impurity mentioned in the drug’s European Pharmacopoeia monograph. The remaining three were unidentified degradation products. LC-MS fragmentation experiments were used to characterize the products. The findings may lead to the suggestion of a more thorough drug degradation mechanism. The Toxtree software (Version 3.1.1) was then used to forecast the toxicity of the degradation products. Additional toxicity determination was carried out by using in-silico method.
采用色谱法对比索洛尔片剂和散装剂的稳定性进行了研究和验证。比索洛尔暴露于氧化剂，如过氧化氢、热(干湿)和光解条件、酸、碱和水水解。然而，在酸、碱、氧化和湿热条件下观察到相当大的降解。建立了该药物在光解和干热条件下的稳定性。采用规格为(250 mm × 4.6 mm, 5 μm)的ODS C-18进行分离，流动相为乙腈-磷酸盐缓冲液(20 mm, pH 8) (60:40, v/v)。根据ICH Q2 (R1)对所有方法验证参数进行验证。活性药物成分的测定不受辅料或降解产物的干扰。在6 ~ 14 μg/mL范围内，反应呈线性。一个降解产物的LC-MS m/z值和碎片模式与药物的欧洲药典各论中提到的杂质相匹配。其余三种是未识别的降解产物。采用LC-MS破碎实验对产物进行表征。这一发现可能会导致更彻底的药物降解机制的建议。然后使用Toxtree软件(版本3.1.1)预测降解产物的毒性。采用硅片法进行附加毒性测定。
{"title":"Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development","authors":"Kavita Chandramore, Sandeep Sonawane","doi":"10.25258/ijpqa.14.3.07","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.07","url":null,"abstract":"The stability of bisoprolol in tablet and bulk form was developed and validated using chromatographic methods. The bisoprolol was exposed to oxidizing agents like hydrogen peroxide, heat (dry and wet) and photolytic conditions, acid, alkali, and water hydrolysis. However, considerable degradation was observed in acid, alkali, oxidative, and wet heat thermal conditions. The drug’s stability under photolytic and dry heat conditions was established. The drug and its degradation products were separated on ODS C-18 with the specification of (250 mm × 4.6 mm, 5 μm) and the mobile phase containing acetonitrile and phosphate buffer (20 mM, pH 8) (60:40, v/v). According to ICH Q2 (R1) all method validation parameters are verified. Determination of the active pharmaceutical ingredient was not interfered by excipients or degradation products. In the 6–14 μg/mL range, the response was shown to be linear. One degradation product’s LC-MS m/z values and fragmentation patterns matched an impurity mentioned in the drug’s European Pharmacopoeia monograph. The remaining three were unidentified degradation products. LC-MS fragmentation experiments were used to characterize the products. The findings may lead to the suggestion of a more thorough drug degradation mechanism. The Toxtree software (Version 3.1.1) was then used to forecast the toxicity of the degradation products. Additional toxicity determination was carried out by using in-silico method.","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":"135867827","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: Determining the in-vivo assessment of Naringenin’s nephroprotective efficacy against Autosomal dominant polycystic kidney disease (ADPKD) and Madin-Darby canine kidney (MDCK) derived cysts. Method: Our research on the molecular mechanism of naringenin, a flavonoid present in plants and berries that has been shown to limit cell growth and protect against cancer in in-vitro and animal models, was conducted using dictyostelium, a simple, controllable biomedical model. Cultured MDCK cells were used to generate differentiated tubule cells, and these findings were extrapolated to a human kidney model employing these cells. Results: While naringenin inhibited growth in dictyostelium, it had no effect on development. In a random-gene-knockout screen, a TRPP2 (polycystin-2) knockout mutant was discovered to be resistant to naringenin’s effects on growth and random-cell movement. Changes in the divalent transient receptor cause polycystic kidney disease type 2 potential cation channel TRPP2. We found that the growth of cysts and MDCK cells might be inhibited by naringenin. Partial resistance to naringenin was achieved in this model by lowering TRPP2 levels via siRNA, as evidenced by the presence of larger cysts following treatment with 3 and 10 M naringenin compared to controls. Naringenin had no effect on chloride secretion. Conclusion: Naringenin’s influence on cell proliferation is mediated by TRPP2 in both dictyostelium and mammalian kidney cells, despite their vast evolutionary distance from one another (polycystin-2). Naringenin will be the subject of more research as a possible new therapeutic treatment for ADPKD
{"title":"In-vivo Evaluation of Nephroprotective Activity of Naringenin against ADPKD and MDCK-derived Cysts","authors":"T.Naga Varalakshmi, V Chitra","doi":"10.25258/ijpqa.14.3.54","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.54","url":null,"abstract":"Aim: Determining the in-vivo assessment of Naringenin’s nephroprotective efficacy against Autosomal dominant polycystic kidney disease (ADPKD) and Madin-Darby canine kidney (MDCK) derived cysts. Method: Our research on the molecular mechanism of naringenin, a flavonoid present in plants and berries that has been shown to limit cell growth and protect against cancer in in-vitro and animal models, was conducted using dictyostelium, a simple, controllable biomedical model. Cultured MDCK cells were used to generate differentiated tubule cells, and these findings were extrapolated to a human kidney model employing these cells. Results: While naringenin inhibited growth in dictyostelium, it had no effect on development. In a random-gene-knockout screen, a TRPP2 (polycystin-2) knockout mutant was discovered to be resistant to naringenin’s effects on growth and random-cell movement. Changes in the divalent transient receptor cause polycystic kidney disease type 2 potential cation channel TRPP2. We found that the growth of cysts and MDCK cells might be inhibited by naringenin. Partial resistance to naringenin was achieved in this model by lowering TRPP2 levels via siRNA, as evidenced by the presence of larger cysts following treatment with 3 and 10 M naringenin compared to controls. Naringenin had no effect on chloride secretion. Conclusion: Naringenin’s influence on cell proliferation is mediated by TRPP2 in both dictyostelium and mammalian kidney cells, despite their vast evolutionary distance from one another (polycystin-2). Naringenin will be the subject of more research as a possible new therapeutic treatment for ADPKD","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"68 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":"135867831","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}
Ganesh B Nigade, Meenakshi N Deodhar, Rajashree S Chavan
Bael avaleha is a semisolid ayurvedic formulation containing the fruit of bael, which acts as an anthelmintic to treat diarrhea, dysentery, and IBS. It strengthens the gastrointestinal tract, heals ulcers, and alleviates abdominal pain. The avleha contains excess sugar, which can result in faster absorption of active ingredients in the biological system. Researchers have begun scrutinizing ayurvedic formulations for quality and consistency, with quality testing being conducted to ensure that the quality of ayurvedic formulations adheres to ayurvedic standards. Phytochemical fingerprinting by spectroscopic and chromatographic techniques is becoming more popular in assessing the efficacy of ayurvedic products. Previous studies evaluated phenolic compounds, flavonoids, monoterpenes, and sesquiterpenes in Bael fruit using Gas Chromatography Mass Spectrometry (GC-MS), HPTLC, and HPLC methods.This study evaluated marketed bael avaleha formulations (BA I and II) for organoleptic characteristics, physical parameters, and phytoconstituents. A UV-vis spectrophotometric study was conducted for quantitative analysis of phytochemicals. The extract of bael avaleha formulations BA I and BA II were found to have a total phenolic content of 42.34 ± 0.090 mg GAE/g and 38.52 ± 0.065 mg GAE/g, a flavonoid content of 14.34 ± 0.070 mg QE/g and 12.42 ± 0.086 mg QE/g, sugar content of 69.44 ± 0.020 mg Glu/g and 67.18 ± 0.065 mg Glu/g, and a reducing sugar content of 31.34 ± 0.025 mg Glu/g and 29.08 ± 0.047 mg Glu/g, respectively. The Fourier transform infrared (FTIR) spectra of extract of bael avaleha formulations were recorded in region 4000–400 cm−1 and confirmed the presence of hydroxy group, aromatic C-H stretch, C=C and C-O group. RP-HPLC method was developed and used for the estimation of gallic acid, scopoletin, umbelliferone, and imperatorin in the extract of Bael avaleha formulations
{"title":"Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gallic Acid, Scopoletin, Umbelliferone, and Imperatorin in Bael avaleha","authors":"Ganesh B Nigade, Meenakshi N Deodhar, Rajashree S Chavan","doi":"10.25258/ijpqa.14.3.29","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.29","url":null,"abstract":"Bael avaleha is a semisolid ayurvedic formulation containing the fruit of bael, which acts as an anthelmintic to treat diarrhea, dysentery, and IBS. It strengthens the gastrointestinal tract, heals ulcers, and alleviates abdominal pain. The avleha contains excess sugar, which can result in faster absorption of active ingredients in the biological system. Researchers have begun scrutinizing ayurvedic formulations for quality and consistency, with quality testing being conducted to ensure that the quality of ayurvedic formulations adheres to ayurvedic standards. Phytochemical fingerprinting by spectroscopic and chromatographic techniques is becoming more popular in assessing the efficacy of ayurvedic products. Previous studies evaluated phenolic compounds, flavonoids, monoterpenes, and sesquiterpenes in Bael fruit using Gas Chromatography Mass Spectrometry (GC-MS), HPTLC, and HPLC methods.This study evaluated marketed bael avaleha formulations (BA I and II) for organoleptic characteristics, physical parameters, and phytoconstituents. A UV-vis spectrophotometric study was conducted for quantitative analysis of phytochemicals. The extract of bael avaleha formulations BA I and BA II were found to have a total phenolic content of 42.34 ± 0.090 mg GAE/g and 38.52 ± 0.065 mg GAE/g, a flavonoid content of 14.34 ± 0.070 mg QE/g and 12.42 ± 0.086 mg QE/g, sugar content of 69.44 ± 0.020 mg Glu/g and 67.18 ± 0.065 mg Glu/g, and a reducing sugar content of 31.34 ± 0.025 mg Glu/g and 29.08 ± 0.047 mg Glu/g, respectively. The Fourier transform infrared (FTIR) spectra of extract of bael avaleha formulations were recorded in region 4000–400 cm−1 and confirmed the presence of hydroxy group, aromatic C-H stretch, C=C and C-O group. RP-HPLC method was developed and used for the estimation of gallic acid, scopoletin, umbelliferone, and imperatorin in the extract of Bael avaleha formulations","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"202 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":"135867453","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}
Sumeet Dwivedi, Udita Singh, Prakash C. Patel, Rahul S. Bijwar, Supriya Shidhaye, Arun Patidar
In the conventional medical system, India’s population depends on ancient medicine systems like Ayurveda, Homeopathy, Siddha and Unani for the treatment of disease. With such a large population relying on herbal remedies, scientific support for the efficacy of herbal products that have been used for a long time is essential. Diabetes is predicted to become more common worldwide. According to WHO, developing nations will bear the majority of the burden. Peristrophe bicalyculata (R) Nees. belongs to the Acanthaceae family. It is native to Afghanistan, Africa and India. The plant’s flowers are used medicinally to treat various diseases and disorders. The present paper shows the antidiabetic activity of hydro-alcoholic extracts of P. bicalyculata (R) Nees flowers was investigated using an animal model.
{"title":"Evaluation of Antidiabetic Activity of Various Extract of Peristrophe bicalyculata (R.) Nees","authors":"Sumeet Dwivedi, Udita Singh, Prakash C. Patel, Rahul S. Bijwar, Supriya Shidhaye, Arun Patidar","doi":"10.25258/ijpqa.14.3.16","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.16","url":null,"abstract":"In the conventional medical system, India’s population depends on ancient medicine systems like Ayurveda, Homeopathy, Siddha and Unani for the treatment of disease. With such a large population relying on herbal remedies, scientific support for the efficacy of herbal products that have been used for a long time is essential. Diabetes is predicted to become more common worldwide. According to WHO, developing nations will bear the majority of the burden. Peristrophe bicalyculata (R) Nees. belongs to the Acanthaceae family. It is native to Afghanistan, Africa and India. The plant’s flowers are used medicinally to treat various diseases and disorders. The present paper shows the antidiabetic activity of hydro-alcoholic extracts of P. bicalyculata (R) Nees flowers was investigated using an animal model.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"70 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":"135867455","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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