Bioanalytical method for estimation of procyclidine in human plasma using liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic study.

Viritha Bezawada, Padma Mogili, Sireesha Dodda, Ramakrishna Gajula
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Abstract

A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for quantification of procyclidine hydrochloride in human plasma using Procyclidine D11 hydrochloride as internal standard. Liquid-liquid extraction technique with methyl tertiary butyl ether was used for the extraction of plasma samples. Chromatographic separation of the analyte and the internal standard from the endogenous components was done on Zodiac C18 column (50 × 4.6 mm, 5 µm) using a mixture of methanol and 0.1% formic acid in water (70:30, v/v) as mobile phase at a flow rate of 1 mL/min with the run time of 2 min. The detection of the eluents was done using multiple reaction monitoring (MRM) in positive ion mode. Linearity of the method was established in the concentration range of 0.5 to 120 ng/mL. Full validation of the method was done as per USFDA guidelines and the results were well within the acceptance limits. The successful application of the method was done on healthy human subjects under fasting conditions, proving it to be used for bioequivalence and bioavailability (BA/BE) studies of procyclidine.

液相色谱-串联质谱法测定人血浆中procylidine的生物分析方法:在药代动力学研究中的应用。
建立了以盐酸procyclidine D11为内标,快速、选择性、灵敏的液相色谱-串联质谱(LC-MS/MS)定量测定人血浆中盐酸procyclidine的方法。采用甲基叔丁基醚液液萃取技术对血浆样品进行萃取。色谱柱为Zodiac C18 (50 × 4.6 mm, 5µm),流动相为甲醇与0.1%甲酸水溶液(70:30,v/v),流速为1 mL/min,运行时间为2 min。在正离子模式下,采用多反应监测(MRM)对洗脱液进行检测。在0.5 ~ 120 ng/mL的浓度范围内建立了线性关系。根据USFDA指南对方法进行了全面验证,结果完全在可接受范围内。该方法在健康人体禁食条件下成功应用,证明该方法可用于procylidine的生物等效性和生物利用度(BA/ be)研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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