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采用电动色谱-逆流技术测定药物制剂中氟西汀对映体

Determination of fluoxetine enantiomers in pharmaceutical formulations by electrokinetic chromatography-counter current technique.

作者信息

Asensi-Bernardi Lucía, Martín-Biosca Yolanda, Fornet-Herrero Eder, Sagrado Salvador, Medina-Hernández María José

机构信息

Departamento de Química Analítica, Facultad de Farmacia, Universidad de Valencia, Burjassot, Valencia, Spain.

出版信息

Biomed Chromatogr. 2013 Mar;27(3):377-81. doi: 10.1002/bmc.2802. Epub 2012 Aug 17.

DOI:10.1002/bmc.2802
PMID:22903652
Abstract

In this work, an electrokinetic chromatography-counter current procedure for the separation of fluoxetine enantiomers using highly sulfated β-cyclodextrin was optimized and applied to the determination of the enantiomers in three pharmaceutical formulations according to the matrix features. Quality criteria were applied to facilitate its transferability to testing laboratories. Fluoxetine was used therapeutically as the racemate, although a stereospecificity associated with its interactions with the neuronal serotonin-uptake carrier was demonstrated. In this context, the development of enantioselective methods for the chiral analysis of pharmaceuticals allowing stereoisomer ratio estimations has increasing interest in pharmaceutical industry. The proposed method allows the quantification of both enantiomers in less than 2 min with high resolution (R(s) = 2.4).

摘要

在本研究中,优化了一种使用高硫酸化β-环糊精的电动色谱-逆流程序来分离氟西汀对映体,并根据基质特征将其应用于三种药物制剂中对映体的测定。应用质量标准以促进其向检测实验室的转移。氟西汀作为消旋体用于治疗,尽管已证明其与神经元5-羟色胺摄取载体相互作用存在立体特异性。在此背景下,开发能够进行立体异构体比例估算的对映体选择性药物手性分析方法在制药行业中越来越受到关注。所提出的方法能够在不到2分钟的时间内以高分辨率(R(s)=2.4)对两种对映体进行定量分析。

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