液相色谱-串联质谱法测定K3edta人血浆中奥氮平的生物分析方法的建立与验证及其在药代动力学研究中的应用

International Journal Of Medical Science And Clinical Invention Pub Date : 2022-05-10 DOI:10.18535/ijmsci/v9i04.03

Jitendra Malviya, D. Joshi, R. Bhadauria

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引用次数: 0

摘要

建立了一种快速、灵敏的LC-MS /MS方法，以奥氮平D3为内标，用于k3EDTA人血浆中奥氮平的生物分析方法开发和验证。使用Oasis HLB 1cc (30mg)萃取筒从血浆中提取分析物和IS，在Cosmosil, 5µm, C18 150*4上分离。6毫米柱，用10毫米甲酸铵水溶液:乙腈(10:90)，流速为1.0 mL/min。检测采用API-4000 LC-MS /MS，电喷雾电离，多反应监测分析。该方法根据FDA指南进行了验证，并在运行时间仅为4.0分钟的可接受范围内提供了日内和日间的精密度和准确度。该方法已成功应用于一项涉及人类男性志愿者单次口服联合片剂的药代动力学研究

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Bioanalytical method Development and Validation for Estimation of Olanzapine in K3edta Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry and Application to a Pharmacokinetic Study

A rapid and sensitive LC–MS/MS method for the bioanalytical method development and validation for estimation of olanzapine in k3EDTA human plasma using Olanzapine D3 as internal standard has been developed and validated. The analytes and IS were extracted from plasma by solid phase extraction using Oasis HLB 1cc (30mg) Extraction Cartridge and separated on a Cosmosil, 5µm, C18 150*4. 6 mmcolumn using a 10 mM ammonium formate in Water: Acetonitrile (10: 90) at a flow rate of 1.0 mL/min. Detection involved an API-4000 LC–MS/MS with electrospray ionization in the positive ion mode and multiple-reaction monitoring for analysis. The method was validated according to FDA guidelines and shown to provide intra- and inter-day precision and accuracy within acceptable limits in a run time of only 4.0 min. The method was successfully applied to a pharmacokinetic study involving a single oral administration of a combination tablet to human male volunteers

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International Journal Of Medical Science And Clinical Invention

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