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高效液相色谱-串联质谱法测定人血浆中的氯马斯汀

High-performance liquid chromatographic-tandem mass spectrometric method for the determination of clemastine in human plasma.

作者信息

Horváth Viola, Tolokán Antal, Egresi Andrea, Pap Tímea, Horvai George, Balogh-Nemes Katalin, Klebovich Imre

机构信息

Research Group of Technical Analytical Chemistry, Hungarian Academy of Sciences-Budapest University of Technology and Economics, Gellért tér 4., Budapest H-1111, Hungary.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Feb 25;816(1-2):153-9. doi: 10.1016/j.jchromb.2004.11.025.

Abstract

A highly sensitive high-performance liquid chromatographic-tandem mass spectrometric method (HPLC-MS-MS) has been developed to quantitate clemastine in human plasma for the purpose of pharmacokinetic studies. Sample preparation was carried out by liquid-liquid extraction using deuterated clemastine as an internal standard. Chromatographic separation used a C18 reversed phase polymer column giving an extremely fast total run time of 2 min. The method was validated and used for the bioequivalence study of clemastine tablets in healthy male volunteers (n=28). The lower limit of detection proved to be 0.01 ng/ml for clemastine.

摘要

为进行药代动力学研究,已开发出一种高灵敏度高效液相色谱 - 串联质谱法(HPLC-MS-MS)来定量测定人血浆中的氯马斯汀。样品制备采用液 - 液萃取法,以氘代氯马斯汀作为内标。色谱分离使用C18反相聚合物柱,总运行时间极快,仅为2分钟。该方法经过验证,并用于健康男性志愿者(n = 28)中氯马斯汀片的生物等效性研究。氯马斯汀的检测下限为0.01 ng/ml。

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