Nela Žideková, Kristián Pršo, Marek Pršo, Miloš Jeseňák, Oldřich Farsa, Martin Kertys
{"title":"Development and Validation of a Rapid and Simple UHPLC–MS/MS Method for the Determination of Colchicine in Human Plasma","authors":"Nela Žideková, Kristián Pršo, Marek Pršo, Miloš Jeseňák, Oldřich Farsa, Martin Kertys","doi":"10.1002/bmc.70222","DOIUrl":null,"url":null,"abstract":"<p>Colchicine is a naturally occurring alkaloid primarily derived from plants of the Colchicum genus, which is used to treat gout and serve as a frontline therapy for various inflammatory conditions, including familial Mediterranean fever. Although it is not recommended for routine therapeutic drug monitoring, there are situations where it may be beneficial, such as in dose adjustments. The present study introduces an LC–MS/MS method for quantifying colchicine in human plasma. A one-step extraction procedure employing an Ostro plate was applied, and the extracts were analyzed using gradient elution followed by detection on a mass spectrometer in multiple reaction monitoring mode. Our method offers several advantages, including a low sample volume and a run time of only 3 min. It demonstrates sufficient linearity to quantify low and high concentrations of colchicine in human plasma samples. The method was successfully validated in accordance with the ICH guideline M10 on bioanalytical method validation, covering selectivity, linearity, limit of quantification, accuracy, precision, dilution integrity, carry-over effect, matrix effects, extraction recovery, and stability over a concentration range of 0.05–100 ng/mL. The fully developed and validated method was applied to determine colchicine in plasma samples from patients diagnosed with familial Mediterranean fever.</p>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 11","pages":""},"PeriodicalIF":1.7000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/bmc.70222","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biomedical Chromatography","FirstCategoryId":"3","ListUrlMain":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/bmc.70222","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
Colchicine is a naturally occurring alkaloid primarily derived from plants of the Colchicum genus, which is used to treat gout and serve as a frontline therapy for various inflammatory conditions, including familial Mediterranean fever. Although it is not recommended for routine therapeutic drug monitoring, there are situations where it may be beneficial, such as in dose adjustments. The present study introduces an LC–MS/MS method for quantifying colchicine in human plasma. A one-step extraction procedure employing an Ostro plate was applied, and the extracts were analyzed using gradient elution followed by detection on a mass spectrometer in multiple reaction monitoring mode. Our method offers several advantages, including a low sample volume and a run time of only 3 min. It demonstrates sufficient linearity to quantify low and high concentrations of colchicine in human plasma samples. The method was successfully validated in accordance with the ICH guideline M10 on bioanalytical method validation, covering selectivity, linearity, limit of quantification, accuracy, precision, dilution integrity, carry-over effect, matrix effects, extraction recovery, and stability over a concentration range of 0.05–100 ng/mL. The fully developed and validated method was applied to determine colchicine in plasma samples from patients diagnosed with familial Mediterranean fever.
期刊介绍:
Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.