{"title":"A novel LC-MS/MS method for simultaneous estimation of chlordiazepoxide and clidinium in human plasma and its application to pharmacokinetic assessment.","authors":"Naveen Kumar Dubey, Peeyush Jain, Ankit Raj, Sandeep Tiwari","doi":"10.1080/17576180.2025.2501921","DOIUrl":"10.1080/17576180.2025.2501921","url":null,"abstract":"<p><p>A highly sensitive and selective LC-MS/MS assay was developed and validated for the simultaneous quantification of Chlordiazepoxide and Clidinium in human plasma for the first time, employing solid-phase extraction. Chromatographic separation of the analytes and their deuterated internal standards was performed on a reversed-phase Kinetex XB-C18 (150 × 4.6 mm, 5 μm) column with a gradient mobile phase. Mass spectrometric detection was achieved using electrospray ionization in positive ion mode, employing the ion transitions: m/z 300.0 → 227.1 for Chlordiazepoxide, m/z 352.1 → 142.1 for Clidinium, m/z 305.1 → 232.1 for Chlordiazepoxide D5, and m/z 357.2 → 142.2 for Clidinium D5. The assay demonstrated a linear calibration range of 504.0-500,198.3 pg/mL for Chlordiazepoxide and 5.0-3,004.7 pg/mL for Clidinium, ensuring precise pharmacokinetic evaluation. The method was validated with a lower limit of quantification (LLOQ) of 504.0 pg/mL for Chlordiazepoxide and 5.0 pg/mL for Clidinium, precision within 15% RSD, and accuracy within 85-115% of the nominal values. No matrix interference from haemolysed or lipemic plasma was observed, and recovery exceeded 90%. This study presents a novel LC-MS/MS method with significant improvements in sensitivity and specificity, facilitating its direct application in pharmacokinetic and bioequivalence studies.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"621-628"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12118435/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-05-01Epub Date: 2025-06-05DOI: 10.1080/17576180.2025.2515009
Nigatu Tadesse Gebrehiwot, Man-Ni He, Juan Li, Hong-Min Liu
{"title":"Challenges of folate species analysis in food and biological matrices by liquid chromatography-tandem mass spectrometery.","authors":"Nigatu Tadesse Gebrehiwot, Man-Ni He, Juan Li, Hong-Min Liu","doi":"10.1080/17576180.2025.2515009","DOIUrl":"10.1080/17576180.2025.2515009","url":null,"abstract":"<p><p>Folates are group of water-soluble B-vitamins indispensable to one carbon metabolism as acceptor and donor of methyl group during purine and pyrimidine biosynthesis, DNA and histone methylations, and in mitochondrial protein translation. The deficiencies associated with risk of neural tube defect, cancer, cardiac and psychiatric disorders. Thus, detecting and quantifying folate species accurately become a crucial step in food omics, disease metabolomics, proteomics, genomics, toxicology, and pharmacokinetics, and regulatory sciences. However, the detection and quantitative determination of folate species yet subjected to analytical challenges due to physio-chemical instability, structural similarity, ultra-trace availability. Advances in liquid chromatography tandem mass spectrometry (LC-MS/MS) method enabled the detection and quantification of folate species in short span of time using low sample volume. However, risk of inter conversion, degradation or loss during sample preparation, coupled with folate isomers and isobars challenged the selectivity, specificity and sensitivity for quantification by LC-MS/MS at trace level. Systematic literature search was conducted through major indexing databases such as Pub med, Embase, and Google Scholar to include the most relevant articles published 2010-2025 in preparing the review highlighting the challenges of folate species analysis in food and biological matrices from sample preparation to mass spectrometry detection with a future perspective on innovative optimization methods.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"681-700"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-04-01Epub Date: 2025-04-21DOI: 10.1080/17576180.2025.2489917
Saleem Javid, K Ramya, Mohammed Gulzar Ahmed, Nafeesath Zahiya, Nafisa Thansheefa, Abdul Kadar Anas, Fathimath Mahfeela, Reeha, Fariz Sha, Rokeya Sultana
{"title":"Bioanalysis of antihypertensive drugs by LC-MS: a fleeting look at the regulatory guidelines and artificial intelligence.","authors":"Saleem Javid, K Ramya, Mohammed Gulzar Ahmed, Nafeesath Zahiya, Nafisa Thansheefa, Abdul Kadar Anas, Fathimath Mahfeela, Reeha, Fariz Sha, Rokeya Sultana","doi":"10.1080/17576180.2025.2489917","DOIUrl":"10.1080/17576180.2025.2489917","url":null,"abstract":"<p><p>Hypertension is a multifaceted cardiovascular disease, a significant risk factor for stroke, heart attack, heart failure, and renal damage. An essential phase in the drug development process is the exploration of effective bioanalytical approaches to investigate drug metabolism and pharmacokinetics precisely. The use of LC-MS has increased significantly over the last 10 years; numerous researchers have made contributions to the field and enhanced the technical capabilities of workflows based on LC-MS. This review provides a critical analysis of the method development and validation of bioanalytical methods using Liquid Chromatography-Mass Spectrometry (LC-MS) of a few antihypertensive drugs, focusing on extraction techniques and validation parameters. Furthermore, a fleeting look at the GLP, regulatory guidelines, machine learning and artificial intelligence in bioanalysis. Despite these advancements, the document identifies gaps in current regulatory guidelines and advocates areas for further research, predominantly concerning matrix effects and the impact of co-medications. The integration of AI tools in LC-MS has shown the potential to revolutionize bioanalytical methods, yet there is still an imperative for global harmonization. We assume that this review will offer a foundation for the research of new strategies and assist in the identification of the optimum relevant methodology parameters for known and emerging antihypertensive drugs.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"17 7","pages":"471-487"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12026161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-04-01Epub Date: 2025-04-04DOI: 10.1080/17576180.2025.2486929
Padmasri Sai Nandana Aravapally, Naveen Chandrasekar, Arvind Verma, Ravi P Shah
{"title":"Strategic approaches to assess and quantify the oxidative stress biomarkers in complex biological systems.","authors":"Padmasri Sai Nandana Aravapally, Naveen Chandrasekar, Arvind Verma, Ravi P Shah","doi":"10.1080/17576180.2025.2486929","DOIUrl":"10.1080/17576180.2025.2486929","url":null,"abstract":"<p><p>Oxidative stress (OS) is an emerging research area in clinical and biological sciences due to its association with various diseases and physiological processes. OS occurs when there is an imbalance between the production of reactive oxygen species (ROS) and the body's ability to neutralize or repair the damage caused. Chronic oxidative stress is linked to diseases like diabetes, cardiovascular diseases, cancer, and neurodegenerative disorders. Accurate monitoring of OS is crucial for diagnosing diseases, evaluating disease progression, and predicting clinical results. Despite challenges in measuring free radicals due to their short half-life and low concentrations, it can be indirectly assessed through biomarkers like lipid peroxidation, DNA damage, and protein oxidation. The most effective analytical techniques for assessing OS biomarkers in various biological fluids were developed. Furthermore, an in-depth exploration of these various analytical methodologies, underscoring their sensitivity, specificity, and reliability in detecting low concentrations of biomarkers across complex matrices is necessary. A comprehensive literature search was conducted using databases such as Google Scholar, PubMed and Reaxys to identify relevant studies on OS biomarkers. This review explores the evolution of these techniques, highlighting advancements in sample preparation procedures and the specifications of each technique, offering a thorough evaluation of biomarker analysis.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"561-574"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-04-01Epub Date: 2025-03-20DOI: 10.1080/17576180.2025.2481021
Ritesh P Bhole, Sonali Labhade, Shilendra S Gurav
{"title":"Conquering PROTAC molecular design and drugability.","authors":"Ritesh P Bhole, Sonali Labhade, Shilendra S Gurav","doi":"10.1080/17576180.2025.2481021","DOIUrl":"10.1080/17576180.2025.2481021","url":null,"abstract":"<p><p>PROTACs are reshaping drug discovery by enabling targeted protein degradation, overcoming the limitations of traditional inhibitors, and addressing previously \"undruggable\" proteins. The present perspective explores advancements in PROTAC molecular design, focusing on ligand discovery, E3 ligase recruitment, and ternary complex optimization. Integrating AI-driven modeling, FBDD, and SBDD accelerates PROTAC development. In contrast, emerging innovations, such as PHOTACs, hypoxia-responsive systems, and Ab-PROTACs, enhance precision and reduce systemic toxicity. Clinical successes, including ARV-110 for castration-resistant prostate cancer and ARV-471 for breast cancer, exemplify their ability to overcome resistance and provide durable effects. PROTACs are expanding into neurodegenerative diseases and rare conditions, highlighting their versatility. By addressing challenges in pharmacokinetics, safety, and scalability, PROTACs are poised to revolutionize precision medicine. This article presents a forward-looking perspective on conquering the molecular design and drugability of PROTACs, paving the path for transformative therapies.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"455-470"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12026086/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development and validation of an antidrug antibody assay for TRK-950 using Melon™ gel and SPEAD pretreatment.","authors":"Reiji Nishio, Keita Nakanaga, Ryosuke Yoshinaga, Akira Kurihara, Fumiyoshi Okano","doi":"10.1080/17576180.2025.2493607","DOIUrl":"10.1080/17576180.2025.2493607","url":null,"abstract":"<p><strong>Aim & methods: </strong>TRK-950, a humanized IgG1 monoclonal antibody against CAPRIN-1, which is reported to be expressed on the cell surface of various forms of cancer, is currently being developed for multiple types of solid cancer. We developed an antidrug antibody (ADA) assay that includes two pretreatment processes for use in clinical trials, namely, Melon™ gel treatment and solid-phase extraction with acid dissociation (SPEAD), to reduce baseline variability between individual serum samples and improve drug tolerance.</p><p><strong>Results: </strong>Comparing the assay with or without the pretreatment process using commercially available human serum samples, the mean response calculated from 18 individual human samples decreased from 327 to 270, and the coefficient of variation decreased from 41% to 16%. The new assay with the two-step pretreatment met the criteria set by the regulatory agency throughout the validation study. We also confirmed the recovery rates of IgG, IgM, and ADA - drug immune complexes after treatment with Melon™ gel. Clinical trials (NCT05423262) employing this improved analytical method have been conducted, and the results confirm the low immunogenicity of TRK-950.</p><p><strong>Conclusion: </strong>The combination of pretreatment with Melon™ gel and SPEAD is applicable for clinical ADA assays.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"515-524"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulated bioanalysis of antibody-drug conjugates using LC-MS.","authors":"Katsunori Ieki, Suguru Fukuda, Shiori Miyawaki, Kazunari Hirowatari","doi":"10.1080/17576180.2025.2490468","DOIUrl":"10.1080/17576180.2025.2490468","url":null,"abstract":"<p><p>Antibody-drug conjugates (ADCs) are emerging as powerful tools in cancer therapy. Evaluating their drug disposition requires the development and validation of analytical methods to obtain accurate quantitative results, which depend on understanding the ADC structural properties and selecting appropriate analytical platforms. Liquid chromatography-mass spectrometry (LC-MS) is a key technology for ADC bioanalysis, enabling the quantification of payloads, linkers, total antibodies, ADCs, and drug-to-antibody ratio (DAR). This review highlights the strategies and challenges in developing analytical methods for quantifying ADC components in biological samples using LC-MS with a focus on their constituent units. In addition, it addresses the validation requirements of these quantitative analytical methods during drug development.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"549-560"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-04-01Epub Date: 2025-04-18DOI: 10.1080/17576180.2025.2471243
Moucun Yuan, Aihua Liu, Bin Xu, Kurt Sales, Shane Karnik, Troy Voelker, Danielle Salha, Jennifer Zimmer, Mark O'Dell, Shashank Gorityala, Amanda Hays, Todd Lester, Gregory Reynolds, Magdalena Tary-Lehmann, Mathilde Yu, Martin Roberge, Katherine Malone, Vimal Patel, Iain Love, Jenny Lin, Manisha Diaz, Tao Xu, Wei Garofolo, Jessica McGregor, Amanda Leskovar, Robert Kernstock, Mario Pellerin, Michael Brown, Adriane Spytko, Stephen Lowes, David Ambrose, Dawn Dufield, Cheikh Kane, Rathna Veeramachaneni, Marsha Luna, Dominic Warrino, Varun Dwivedi, Allan Xu, Elizabeth Hyer, Tracy Iles, Ritankar Majumdar, Daniel Sikkema, Eric Thomas, Annika Carlsson, Naveen Dakappagari, Nathan Riccitelli, Chantal Di Marco, Mohammed Bouhajib, Adriana Iordachescu, Mitesh Sanghvi, Hollie Barton, Amy Lavelle, Elizabeth Dompkowski, Stephen Rundlett, Katie Matys, Tim Sangster, Annelies Turksma, Weihua Gu, Jia Liu, Brian Hoffpauir, Agostinho Rocha, John Pirro, Jerome Bergeron, Kyla O'Brien, Xinping Fang, Kelly Dong, Jim Yamashita
{"title":"Recommendations on biomarker assay validation (BAV) in tissues by GCC.","authors":"Moucun Yuan, Aihua Liu, Bin Xu, Kurt Sales, Shane Karnik, Troy Voelker, Danielle Salha, Jennifer Zimmer, Mark O'Dell, Shashank Gorityala, Amanda Hays, Todd Lester, Gregory Reynolds, Magdalena Tary-Lehmann, Mathilde Yu, Martin Roberge, Katherine Malone, Vimal Patel, Iain Love, Jenny Lin, Manisha Diaz, Tao Xu, Wei Garofolo, Jessica McGregor, Amanda Leskovar, Robert Kernstock, Mario Pellerin, Michael Brown, Adriane Spytko, Stephen Lowes, David Ambrose, Dawn Dufield, Cheikh Kane, Rathna Veeramachaneni, Marsha Luna, Dominic Warrino, Varun Dwivedi, Allan Xu, Elizabeth Hyer, Tracy Iles, Ritankar Majumdar, Daniel Sikkema, Eric Thomas, Annika Carlsson, Naveen Dakappagari, Nathan Riccitelli, Chantal Di Marco, Mohammed Bouhajib, Adriana Iordachescu, Mitesh Sanghvi, Hollie Barton, Amy Lavelle, Elizabeth Dompkowski, Stephen Rundlett, Katie Matys, Tim Sangster, Annelies Turksma, Weihua Gu, Jia Liu, Brian Hoffpauir, Agostinho Rocha, John Pirro, Jerome Bergeron, Kyla O'Brien, Xinping Fang, Kelly Dong, Jim Yamashita","doi":"10.1080/17576180.2025.2471243","DOIUrl":"10.1080/17576180.2025.2471243","url":null,"abstract":"<p><p>Biomarker analysis enables a deep understanding of physiological and biological processes and offers insights into pathological disease states and conditions. When measured in tissues, the spatial distribution of biomarkers may be evaluated. To meet regulatory and sponsor requirements, guidance on the approach to validation and the parameters to be evaluated is essential. The main goals of this GCC white paper are to disseminate the survey results discussed during the 16<sup>th</sup>& 17<sup>th</sup>GCC Closed Forums (2023 & 2024) and to provide recommendations from the GCC members on technical and regulatory considerations for the bioanalysis of biomarkers in tissues.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"17 7","pages":"429-438"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12026151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-04-01Epub Date: 2025-03-25DOI: 10.1080/17576180.2025.2479963
Sanam Ahmad, Fabian Gärtner, Rosie Penford, Lisa Wolter, Sonya Belle, Alexandra Bushby, Mariana Carneiro Da Cunha, Brian Dan, Andrea Di Ianni, Caroline Dumolyn, Marie Sole Giordano, Eva Hanckmann, Jayshree Maher, Elisa Milandri, Kyriel Pineault, Amelia Roberts, Marie Reille-Seroussi, Sara Russo, Manca Spendal, Claire Szuster, Kevin Vandenbroucke, Aline Vollmer, Friederike Vogt, Simon Wellenberg, Philip Timmerman
{"title":"Feedback from the 10th European Bioanalysis Forum Young Scientist Symposium and from the Science Café discussions on sustainability in bioanalysis.","authors":"Sanam Ahmad, Fabian Gärtner, Rosie Penford, Lisa Wolter, Sonya Belle, Alexandra Bushby, Mariana Carneiro Da Cunha, Brian Dan, Andrea Di Ianni, Caroline Dumolyn, Marie Sole Giordano, Eva Hanckmann, Jayshree Maher, Elisa Milandri, Kyriel Pineault, Amelia Roberts, Marie Reille-Seroussi, Sara Russo, Manca Spendal, Claire Szuster, Kevin Vandenbroucke, Aline Vollmer, Friederike Vogt, Simon Wellenberg, Philip Timmerman","doi":"10.1080/17576180.2025.2479963","DOIUrl":"10.1080/17576180.2025.2479963","url":null,"abstract":"<p><p>Since 2014, the European Bioanalysis Forum has organized the Young Scientist Symposium, providing early-career scientists with unique development opportunities. By fostering a peer community, this initiative has successfully lowered barriers to engagement in cross-company, pre-competitive interactions. Since 2018, the symposium has included the Science Café roundtable, further reinforcing the European Bioanalysis Forum's commitment to supporting young scientists beyond their scientific expertise by promoting broader professional development.This manuscript summarizes discussions from the 10th Young Scientist Symposium, held in Hasselt, Belgium, from May 15-17, 2024. The symposium featured presentations on new technologies, biomarker assays, troubleshooting, and microsampling. Additionally, it provides insights from the Science Café discussions, which focused on sustainability in the bioanalytical laboratory.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"509-514"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087919/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BioanalysisPub Date : 2025-04-01Epub Date: 2025-03-24DOI: 10.1080/17576180.2025.2481023
Peddaguravagari Mounika, Mariya Shelby, Chethan K S, Honnavalli Yogish Kumar, Bannimath Gurupadayya
{"title":"A chiral HPLC and pharmacokinetic approach of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide.","authors":"Peddaguravagari Mounika, Mariya Shelby, Chethan K S, Honnavalli Yogish Kumar, Bannimath Gurupadayya","doi":"10.1080/17576180.2025.2481023","DOIUrl":"10.1080/17576180.2025.2481023","url":null,"abstract":"<p><strong>Aim: </strong>The main purpose of the study is to establish Bioanalytical method development for enantiomeric divergence and Stereoselective Pharmacokinetic activity of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide(B06).</p><p><strong>Background: </strong>Isoquinoline derivatives have various activities like anticancer, anti-convulsant etc. The proposed project is mainly focused on anti-cancer activity of the synthesized B-06 compound as it shown very good cytotoxicity activity on MBA-MD-231 and MCF-7 cell lines by using SRB assay.</p><p><strong>Method: </strong>The specified project was completed with HPLC and an amylose chiral column. The bioanalytical approach was developed and tested using Wister Albino rats in compliance with USFDA Guidelines and expanded to include pharmacokinetic activities.</p><p><strong>Result: </strong>Data that had previously been published was used to design the B06 compound. RT of 9.578 and 7.076 minutes were observed for (R) &; (S) B06 Compound. Within-run and between-run precision for S-enantiomer varied from 0.28 to 6.078%, while R-enantiomer was found to range from 0.34 to 6.08%. Recovery rates ranged from 80.06% to 92.60% for both enantiomers. Pharmacokinetic investigations were developed and validated by using PKSolver software with Microsoft Excel.</p><p><strong>Conculsion: </strong>We successfully established optimized bioanalytical method for pharmacokinetic study were both the enantiomers were properly separated. In pharmacokinetic activity we found that the enantiomers are non-stereoselective having same absorption rate.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"445-453"},"PeriodicalIF":1.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12026118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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