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高效薄层色谱法检测和测定人血浆中的兰索拉唑及其在药代动力学研究中的应用。

High-performance thin-layer chromatographic method for the detection and determination of lansoprazole in human plasma and its use in pharmacokinetic studies.

作者信息

Pandya K K, Mody V D, Satia M C, Modi I A, Modi R I, Chakravarthy B K, Gandhi T P

机构信息

Department of Phytochemistry, R & D, Cadila Pharmaceuticals Ltd., Ahmedabad, India.

出版信息

J Chromatogr B Biomed Sci Appl. 1997 May 23;693(1):199-204. doi: 10.1016/s0378-4347(96)00516-6.

Abstract

A rapid and sensitive high-performance thin-layer chromatography (HPTLC) method has been developed for the measurement of lansoprazole in human plasma and its use for pharmacokinetic study has been evaluated. Detection and quantitation were performed without using an internal standard. A single stage extraction procedure was followed for extracting lansoprazole from plasma and a known amount of the extract was spotted on precoated silica gel 60 F254 plates using a Camag Linomat IV autosampler. Lansoprazole was quantified using a Camag TLC Scanner 3. The recovery study of authentic analytes added to plasma at 0.05 to 0.25 microg/ml was 95.37+/-2.15% and the lowest amount of lansoprazole that could be detected was 20 ng/ml plasma. The method provides a direct estimate of the amount of lansoprazole present in plasma. The method was used for the determination of plasma levels as well as pharmacokinetic parameters of lansoprazole after oral administration of two marketed preparations to healthy volunteers.

摘要

已开发出一种快速灵敏的高效薄层色谱(HPTLC)方法用于测定人血浆中的兰索拉唑,并评估了其在药代动力学研究中的应用。检测和定量无需使用内标。采用单步萃取程序从血浆中提取兰索拉唑,使用Camag Linomat IV自动进样器将已知量的提取物点样于预涂硅胶60 F254板上。使用Camag TLC Scanner 3对兰索拉唑进行定量。向血浆中添加浓度为0.05至0.25微克/毫升的真实分析物的回收率研究结果为95.37±2.15%,可检测到的兰索拉唑的最低量为20纳克/毫升血浆。该方法可直接估算血浆中兰索拉唑的含量。该方法用于测定健康志愿者口服两种市售制剂后血浆中兰索拉唑的水平以及药代动力学参数。

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