高效液相色谱-质谱联用/质谱联用测定人血浆中秋水仙碱的方法建立及验证

IF 1.7 4区 医学 Q4 BIOCHEMICAL RESEARCH METHODS
Nela Žideková, Kristián Pršo, Marek Pršo, Miloš Jeseňák, Oldřich Farsa, Martin Kertys
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引用次数: 0

摘要

秋水仙碱是一种天然存在的生物碱,主要来源于秋水仙属植物,用于治疗痛风,并作为各种炎症的一线治疗方法,包括家族性地中海热。虽然不推荐用于常规治疗药物监测,但在某些情况下,它可能是有益的,例如剂量调整。本研究介绍了一种hplc - MS/MS定量测定人血浆中秋水仙碱的方法。采用Ostro板一步提取,梯度洗脱,质谱仪检测,多反应监测模式。我们的方法具有几个优点,包括低样本量和运行时间仅为3分钟。它显示了充分的线性定量低和高浓度秋水仙碱在人血浆样品。该方法按照ICH生物分析方法验证指南M10成功验证,包括选择性、线性、定量限、准确度、精密度、稀释完整性、携带效应、基质效应、提取回收率和浓度范围为0.05-100 ng/mL的稳定性。应用完全开发和验证的方法测定家族性地中海热患者血浆样本中的秋水仙碱。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Development and Validation of a Rapid and Simple UHPLC–MS/MS Method for the Determination of Colchicine in Human Plasma

Development and Validation of a Rapid and Simple UHPLC–MS/MS Method for the Determination of Colchicine in Human Plasma

Development and Validation of a Rapid and Simple UHPLC–MS/MS Method for the Determination of Colchicine in Human Plasma

Development and Validation of a Rapid and Simple UHPLC–MS/MS Method for the Determination of Colchicine in Human Plasma

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.

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来源期刊
Biomedical Chromatography
Biomedical Chromatography 生物-分析化学
CiteScore
3.60
自引率
5.60%
发文量
268
审稿时长
2.3 months
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.
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