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一种快速灵敏的液相色谱/串联质谱法同时测定人血浆中阿魏酸及其主要代谢物对羟基阿魏酸:应用于药代动力学和生物等效性研究。

A rapid and most sensitive liquid chromatography/tandem mass spectrometry method for simultaneous determination of alverine and its major metabolite, para hydroxy alverine, in human plasma: application to a pharmacokinetic and bioequivalence study.

机构信息

Contract Research Organization, Cadila Pharmaceuticals Limited, 1389-Trasad Road, Dholka, Gujarat, India.

出版信息

Drug Test Anal. 2010 Jun;2(6):284-91. doi: 10.1002/dta.130.

Abstract

A rapid and highly sensitive method for the determination of alverine (ALV) and its metabolite, para hydroxy alverine (PHA), in human plasma using LC-MS/MS in positive ion electrospray ionization (ESI) in multiple reactions monitoring (MRM) mode was developed and validated. The procedure involves a simple solid phase extraction (SPE). Chromatographic separation was carried out on a Hypersil GOLD C(18) column (50 mm x 4.6 mm, 5 microm) with an isocratic mobile phase and a total run time of 1.5 min. The standard calibration curves showed excellent linearity within the range of 0.060-10.051 ng/mL for ALV and 0.059-10.017 ng/mL for PHA (r > or = 0.990). This method was successfully applied to a pharmacokinetic study after oral administration of alverine citrate 120 mg capsule in Indian healthy male volunteers.

摘要

建立了一种灵敏、快速的测定人血浆中苯甲辛可宁(ALV)及其代谢产物对羟基苯甲辛可宁(PHA)的 LC-MS/MS 方法,采用正离子电喷雾(ESI)、多反应监测(MRM)模式。该方法采用固相萃取(SPE)技术,以 Hypersil GOLD C18 柱(50mm×4.6mm,5μm)为色谱柱,以等度洗脱,总运行时间为 1.5min。ALV 在 0.060-10.051ng/mL 范围内、PHA 在 0.059-10.017ng/mL 范围内线性关系良好(r≥0.990)。该方法成功地应用于印度健康男性志愿者口服柠檬酸苯甲辛可宁胶囊 120mg 后的药代动力学研究。

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