IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-26 DOI: 10.1080/17576180.2025.2509480

Hong Chen, Kewei Liu, Jiawen Zhang, Xihong Zhao, Yatian Wang, Xiumei Lu, Feng Qin

{"title":"A rapid and sensitive UHPLC-MS/MS method for epalrestat detection in micro-volumes of human plasma for the first time.","authors":"Hong Chen, Kewei Liu, Jiawen Zhang, Xihong Zhao, Yatian Wang, Xiumei Lu, Feng Qin","doi":"10.1080/17576180.2025.2509480","DOIUrl":"https://doi.org/10.1080/17576180.2025.2509480","url":null,"abstract":"Aim: A rapid and sensitive ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method was developed and validated for epalrestat detection in human plasma.Materials and methods: A triple quadrupole tandem mass spectrometer equipped with an electrospray ionization (ESI) source was used to quantify epalrestat and the internal standard epalrestat-d5 in the negative ion mode using multiple reaction monitoring (MRM). After acetonitrile-mediated protein precipitation, chromatographic separation was achieved using a reversed-phase C18 column (ACQUITY UPLC BEH, 2.1 × 50 mm, 1.7 μm; Waters Corp) with acetonitrile and 2 mM ammonium acetate in water as the mobile phase through gradient elution.Results and conclusion: The retention time of epalrestat was 0.92 min and the entire run time was only 2.00 min. The calibration curve was linear in the range 10.0-8.00 × 103 ng/mL (r ≥ 0.99). The within-run and between-run relative standard deviations (RSDs) were < 9.3%. The within-run and between-run relative errors (REs) ranged -8.4-4.2%. No significant matrix effects were observed and the recovery rate was high. The method was fully validated, including reinjection reproducibility in human plasma, and was successfully applied in a pharmacokinetic study, in which 100% incurred sample reanalysis met the criteria.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-11"},"PeriodicalIF":1.9,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Validated GC-MS methods to detect ethylene, diethylene, and triethylene glycol in serum, plasma, and urine samples. 验证气相色谱-质谱法检测血清、血浆和尿液样本中的乙烯、二乙烯和三甘醇。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-22 DOI: 10.1080/17576180.2025.2506352

Nicolas Abrigo, Susan Daniela Selaya, Adil Mohammad, Diaa Shakleya, Dustin G Brown, Jinhui Zhang, Valerie Pratt, Jody E Green, Amanda Degunia, Michael Bennett, Kaitlyn Bloom, Lynnette Rogers, Aiman Q Khan, Robert O Heuckeroth, Patrick J Faustino

{"title":"Validated GC-MS methods to detect ethylene, diethylene, and triethylene glycol in serum, plasma, and urine samples.","authors":"Nicolas Abrigo, Susan Daniela Selaya, Adil Mohammad, Diaa Shakleya, Dustin G Brown, Jinhui Zhang, Valerie Pratt, Jody E Green, Amanda Degunia, Michael Bennett, Kaitlyn Bloom, Lynnette Rogers, Aiman Q Khan, Robert O Heuckeroth, Patrick J Faustino","doi":"10.1080/17576180.2025.2506352","DOIUrl":"10.1080/17576180.2025.2506352","url":null,"abstract":"Background: While Polyethylene glycol 3350 (PEG 3350) is approved by the USFDA for short term use by adults, it is commonly recommended for use in constipated children. Multiple reports of adverse events in children taking PEG 3350 raised safety concerns suggesting that low molecular weight species of PEG 3350 might be absorbed from the gut and cause side effects such as ethylene glycol (EG), diethylene glycol (DEG), and triethylene glycol (TEG).Research design and methods: This article documents the development, validation, and application of analytical methods using GC-MS and GC-MS/MS for the quantitation of EG, DEG, and TEG in human plasma, serum, and urine.Results: The analytical range for EG, DEG, and TEG was 2-20 µg/mL. The sample preparation process involves derivatization using N,O-bis(trimethylsilyl) trifluoroacetamide with 1% trimethylchlorosilane in each biological matrices. Deuterated internal standards for each of the analytes were included to provide accurate quantitation of the glycol analytes.Conclusions: The validated methods were applied to analyze samples a pilot study of children taking PEG 3350. DEG and TEG were detected at levels below the limit of quantitation. In summary, a platform of analytical methods was developed to evaluate glycol analogs in urine, serum, and plasma clinical samples.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-10"},"PeriodicalIF":1.9,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

LC-MS/MS determination of trazodone in human plasma and its pharmacokinetic study in healthy Chinese. 人血浆中曲唑酮的LC-MS/MS测定及其在健康人群中的药动学研究。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-15 DOI: 10.1080/17576180.2025.2506349

Kaiwei Luo, Danrui Liu, Shengshuo Zhang, Xin Zhang, Qunan Cheng, Jie Lin, Yonghua Yu

引用次数: 0

Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum. 欧洲生物分析论坛最近关于挑战三级免疫原性测试策略的讨论和建议。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-04-09 DOI: 10.1080/17576180.2025.2487377

Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman

{"title":"Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.","authors":"Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman","doi":"10.1080/17576180.2025.2487377","DOIUrl":"10.1080/17576180.2025.2487377","url":null,"abstract":"The European Bioanalysis Forum, in discussions with cross-industry experts from pharmaceutical, biotech, and contract research organizations, is continuing the challenge of the traditional 3-Tier immunogenicity testing strategy, proposing a simpler, context-driven 1-Tier approach, a recent paradigm shift that emphasizes clinical relevance and the impact of anti-drug antibodies over mere incidence. In a workshop at the 17th annual Open Symposium, the meeting highlighted using signal-to-noise ratios to assess low-level ADA responses and addressed challenges such as nonspecific binding and assay reliability. Participants debated the need for continued confirmatory testing, and that it should be performed on a case-by-case basis. The shift aims to improve clinical testing strategies while reducing complexity, promoting data-driven decisions. Case studies, particularly from high-risk molecules, will guide implementation. Overall, there's strong support for the 1-Tier approach, but its success depends on robust data, industry collaboration, and regulatory approval.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"575-578"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Integrating metering capabilities to increase the utility of self-collected, dried samples. 集成计量功能，以增加自收集，干燥样品的效用。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-07 DOI: 10.1080/17576180.2025.2501927

Amanda Code, Brandon T Johnson, Charles R Mace

引用次数: 0

Determination of drugs of abuse in oral fluid using dried oral fluid spot assisted by 24-well plate and LC-MS/MS. 24孔板辅助干口服液斑法和LC-MS/MS法测定口服液中滥用药物。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-22 DOI: 10.1080/17576180.2025.2506348

Gabriela Ramos Borges, Bruno Pereira Dos Santos, Giovanna Cristiano de Gouveia, Carolina Silveira Dalanhol, Juliana Nichterwitz Scherer, Sarah Eller, Tiago Franco de Oliveira

{"title":"Determination of drugs of abuse in oral fluid using dried oral fluid spot assisted by 24-well plate and LC-MS/MS.","authors":"Gabriela Ramos Borges, Bruno Pereira Dos Santos, Giovanna Cristiano de Gouveia, Carolina Silveira Dalanhol, Juliana Nichterwitz Scherer, Sarah Eller, Tiago Franco de Oliveira","doi":"10.1080/17576180.2025.2506348","DOIUrl":"https://doi.org/10.1080/17576180.2025.2506348","url":null,"abstract":"Background: Oral fluid has proven to be an excellent matrix for drug testing. Several analytical techniques are available, including the use of dried spots, which have gained increasing recognition in recent years. In this study, a new method was developed and validated using dried oral fluid spot (DOFS) assisted by a 24-well plate for the simultaneous determination of thirteen drugs of abuse and metabolites in oral fluid by LC - MS/MS.Methods: Samples were collected by expectoration and diluted with water. A 100 μL aliquot of sample was applied onto the spot, dried for 60 min, and extracted with 250 μL of acetonitrile:methanol (3:1). The method was validated according to the ANSI/ASB Standard 036 guideline, and 86 oral fluid samples were analyzed.Results: The limits of quantification ranged from 1 to 5 ng/mL, and all calibration curves were linear. Precisions ranged from 2.0 to 13.0% and Bias fluctuated from -19.7 to 9.6%. Ionization suppression or enhancement was noted at -16.2 to 16.6%. Among the analyzed samples, 86% tested positive for at least one substance.Conclusions: The findings confirm that the proposed method was successfully validated, providing a new bioanalytical approach for the detection of drugs of abuse in oral fluid.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"17 9","pages":"595-605"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessing linearity of vaccine immunogenicity assays: application and link with clinical endpoints. 评估疫苗免疫原性测定的线性：应用和与临床终点的联系。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-13 DOI: 10.1080/17576180.2025.2501934

Capucine Lepers, Aurélie Bellanger, Oana Petrof, Martin Verniquet, Mikaël Le Bouter, Cédric Taverne

{"title":"Assessing linearity of vaccine immunogenicity assays: application and link with clinical endpoints.","authors":"Capucine Lepers, Aurélie Bellanger, Oana Petrof, Martin Verniquet, Mikaël Le Bouter, Cédric Taverne","doi":"10.1080/17576180.2025.2501934","DOIUrl":"10.1080/17576180.2025.2501934","url":null,"abstract":"Assessing the performance of an immunogenicity assay before using it to support vaccine clinical trials is mandatory. Further validation of assay performance is even requested to support Phase III studies. While assay validation requires adherence to predefined acceptance criteria, there is no universal stringency level for earlier phases of assay development. Setting scientifically sound criteria for success is about finding the right balance between unavoidable assay limitations and ensuring the assay is fit-for-purpose. In this paper, we focus on the evaluation of linearity for immunogenicity assays and its use as surrogate for accuracy evaluation in the absence of reference material. We propose a simple method for evaluating assay linearity and understanding the impact of a linearity deviation on the evaluation of the response increase in clinical trial. Assessment is reliable in absence of known concentration samples, unlike methods in industry guidance, making the proposed method more versatile. Method is illustrated by two case studies, representative of the assays used in the vaccine field. Making the link between assay linearity and clinical endpoints provides a simple and clear framework to support the definition of assay validation criteria, applicable to a variety of immunogenicity assays.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"583-594"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Validation of UV-Vis spectrophotometric colorimetric methods for Rifampicin quantification in PBS & biological matrices. 紫外-可见分光光度比色法在PBS和生物基质中定量利福平的验证。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-14 DOI: 10.1080/17576180.2025.2501942

Elma Ninta Br Ginting, Giovanni Valerio Lembang, Dian Arnita Putri Abdullah, Siti Sri Rejeki Nurrakhma, Muh Rayhan Iskandar Ridwan, Andi Dian Permana

{"title":"Validation of UV-Vis spectrophotometric colorimetric methods for Rifampicin quantification in PBS & biological matrices.","authors":"Elma Ninta Br Ginting, Giovanni Valerio Lembang, Dian Arnita Putri Abdullah, Siti Sri Rejeki Nurrakhma, Muh Rayhan Iskandar Ridwan, Andi Dian Permana","doi":"10.1080/17576180.2025.2501942","DOIUrl":"10.1080/17576180.2025.2501942","url":null,"abstract":"Background: Rifampicin (RIF) is the main treatment for tuberculous meningitis (TBM), but its limited penetration across the blood-brain barrier significantly reduces its therapeutic efficacy. To address this limitation, smart-pH nanoparticles were designed to release RIF in inflamed area and incorperated into a thermosensitive in situ gel for enhanced drug delivery via the olfactory nerve.Methods: UV-Vis spectrophotometry and colorimetric methods to quantify RIF in various media and biological matrices, including phosphate-buffered saline (PBS) at pH 7.4 and 5.0, plasma, and brain tissue. The main validation parameters assessed were selectivity, specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, extraction recovery, and dilution integrity.Result: Method validation followed International Council for Harmonization (ICH) guidelines, demonstrating excellent linearity (r2 = 0.999) and lower limit detection (LOD) of approximately 0,25-0.49 μg/mL were achieved in all media. The method demonstrated high accuracy (%RE -11.62% to 14.88%) and precision (%RSD 2.06% to 13.29%), meeting regulatory requirements.Conclusion: This validated approach enables reliable RIF quantification in biological samples, supporting its application in in vitro release studies, ex vivo permeability studies, and in vivo pharmacokinetic evaluations. These findings contribute to the advancement of targeted drug delivery systems for TBM treatment.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"607-620"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A novel LC-MS/MS method for simultaneous estimation of chlordiazepoxide and clidinium in human plasma and its application to pharmacokinetic assessment. LC-MS/MS同时测定人血浆中氯二氮环氧化物和clidinium的方法及其在药代动力学评价中的应用。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-14 DOI: 10.1080/17576180.2025.2501921

Naveen Kumar Dubey, Peeyush Jain, Ankit Raj, Sandeep Tiwari

{"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":"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.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"621-628"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Bioanalysis of antihypertensive drugs by LC-MS: a fleeting look at the regulatory guidelines and artificial intelligence. 用LC-MS进行抗高血压药物的生物分析：对监管指南和人工智能的短暂回顾。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-04-01 Epub Date: 2025-04-21 DOI: 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":"https://doi.org/10.1080/17576180.2025.2489917","url":null,"abstract":"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.","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}

引用次数: 0

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