选择性、灵敏、快速液相色谱-串联质谱法测定人血浆中格列美脲

Lalit Dutta, Syed Imran Ahmad, Sanjeev Mishra, A. Khuroo, T. Monif
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引用次数: 2

摘要

建立了液相色谱-串联质谱法(LC-MS-MS)测定人血浆中格列美脲的方法并进行了验证。采用固相萃取法从血浆中提取格列美脲和格列美脲-d4(内标品),在C18分析柱上采用等压流动相进行色谱分析。采用多反应监测(MRM)模式,采用正电喷雾电离(ESI+)进行检测。色谱分离在2 min内完成。在1.00 ~ 500.00 ng/mL范围内建立线性关系,决定系数(r2)为0.9981或更大。定量下限为1.00 ng/mL,精密度为3.8%。该方法重复性好,日内精密度<11.3%,日间精密度<11.0%。该方法成功地应用于人血浆中格列美脲的定量,为临床和药代动力学研究提供了支持。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Selective, sensitive, and rapid liquid chromatography – tandem mass spectrometry method for determination of Glimepiride in human plasma
An analytical method based on liquid chromatography–tandem mass spectrometry (LC-MS-MS) was developed and validated for the determination of glimepiride in human plasma. Glimepiride and glimepiride-d4 (internal standard) were extracted from the plasma by solid phase extraction and chromatographed on a C18 analytical column using an isocratic mobile phase. Detection was carried out by positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode. The chromatographic separation was obtained within 2 min. Linearity was established from 1.00–500.00 ng/mL with a coefficient of determination (r2) of 0.9981 or greater. The lower limit of quantitation (LOQ) was identifiable and reproducible at 1.00 ng/mL with a precision of 3.8%. The method has shown remarkable reproducibility, with intra- and inter-day precision and accuracy <11.3% and <11.0%, respectively. The method was successfully applied for the quantitation of glimepiride in human plasma to support clinical and pharmacokinetic studies.
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