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硫酸化β-环糊精介导的毛细管电泳法拆分西替利嗪对映体

Enantioseparation of cetirizine by sulfated-beta-cyclodextrin-mediated capillary electrophoresis.

作者信息

Chou Yu-Wei, Huang Wei-Shan, Ko Chen-Chun, Chen Su-Hwei

机构信息

Faculty of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.

出版信息

J Sep Sci. 2008 Mar;31(5):845-52. doi: 10.1002/jssc.200700487.

Abstract

A sulfated beta-cyclodextrin (sulfated beta-CD)-mediated capillary electrophoresis method is described for the enantioseparation of cetirizine using achiral cefazolin as an internal standard. The enantioseparation of the drug was performed in a borate buffer (5 mM, pH 8.7) with 1% sulfated beta-CD (w/v) as chiral selector at 10 kV. Several parameters affecting the separation were studied, including the pH and the concentration of borate buffer and chiral selector. Under optimized conditions, a baseline separation of two enantiomers was achieved in less than 7 min. Using cefazolin as an internal standard (IS), the linear range of the method for the determination of levocetirizine was over 1.0 to 50.0 microg/mL; the detection limit (signal-to-noise ratio = 3) of levocetirizine was 0.5 microg/mL. The method allowed the enantioseparation of cetirizine in bulk samples and enantiomeric purity evaluation of levocetirizine (R-enantiomer) in pharmaceutical tablets (Xyzal), and it was also found to be suitable for enantioseparation in human plasma.

摘要

描述了一种硫酸化β-环糊精(硫酸化β-CD)介导的毛细管电泳方法,该方法以非手性头孢唑林作为内标物用于西替利嗪的对映体分离。在硼酸盐缓冲液(5 mM,pH 8.7)中,以1%硫酸化β-CD(w/v)作为手性选择剂,在10 kV电压下进行该药物的对映体分离。研究了影响分离的几个参数,包括硼酸盐缓冲液和手性选择剂的pH值和浓度。在优化条件下,不到7分钟即可实现两种对映体的基线分离。以头孢唑林作为内标物(IS),该方法测定左西替利嗪的线性范围为1.0至50.0 μg/mL;左西替利嗪的检测限(信噪比 = 3)为0.5 μg/mL。该方法可用于批量样品中西替利嗪的对映体分离以及药物片剂(仙特明)中左西替利嗪(R-对映体)的对映体纯度评估,并且还发现该方法适用于人血浆中的对映体分离。

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