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一种通过直接注射人血浆和二维非手性-手性色谱法测定莫达非尼对映体、(±)-莫达非尼酸和莫达非尼砜血浆水平的方法。

A method for determination of the plasma levels of modafinil enantiomers, (+/-)-modafinic acid and modafinil sulphone by direct human plasma injection and bidimensional achiral-chiral chromatography.

作者信息

Cass Quezia B, Ferreira Galatti Túlio

机构信息

Departamento de Química, Universidade Federal de São Carlos, CEP 13656-905, Cx. Postal 676, São Carlos, Brazil.

出版信息

J Pharm Biomed Anal. 2008 Apr 14;46(5):937-44. doi: 10.1016/j.jpba.2007.03.004. Epub 2007 Mar 13.

DOI:10.1016/j.jpba.2007.03.004
PMID:17478071
Abstract

Coupled-column separation using restricted access media as the first dimension in order to exclude macromolecules and retain micromolecules has been successfully used for a number of biological fluids. This paper describes the first method developed and validated for the analysis in a single run of the enantiomers of modafinil and its two major metabolites. The method was developed using a bidimensional HPLC system by coupling a restricted access medium (RAM) bovine serum albumin (BSA) column (1.0 cm x 0.46 cm i.d.) to an amylose tris[(S)-1-phenylethylcarbamate] chiral column. The method was fully validated and showed good linearity, precision, accuracy, sensitivity and selectivity, allowing it to be used for pharmacokinetic studies. The quality of the performance of both columns was maintained with over 280 plasma injections of 100 microl.

摘要

使用受限进样介质作为第一维进行柱耦合分离以排除大分子并保留小分子,已成功应用于多种生物流体。本文描述了首个开发并验证的方法,可在单次运行中分析莫达非尼及其两种主要代谢物的对映体。该方法采用二维高效液相色谱系统,将受限进样介质(RAM)牛血清白蛋白(BSA)柱(内径1.0 cm×0.46 cm)与直链淀粉三[(S)-1-苯乙基氨基甲酸酯]手性柱相耦合。该方法经过充分验证,具有良好的线性、精密度、准确度、灵敏度和选择性,可用于药代动力学研究。通过100微升的280多次血浆进样,两根柱的性能质量得以保持。

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