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采用羧乙基-β-环糊精通过毛细管电泳法测定药品中的二甲茚定对映体。

Determination of dimethindene enantiomers in pharmaceuticals by capillary electrophoresis with carboxyethyl-beta-cyclodextrin.

作者信息

Mikus P, Kubacák P, Valásková I, Havránek E

机构信息

Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University, Odbojárov 10, SK-832 32 Bratislava, Slovak Republic.

出版信息

Pharmazie. 2007 Jan;62(1):31-3.

Abstract

Cyclodextrin-mediated capillary zone electrophoresis in a hydrodynamically closed separation system with suppressed electroosmotic flow and UV absorbance photometric detection was developed for a high effective separation and quantitation of dimethindene enantiomers in various pharmaceutical formulations (solution, gel, capsules). The running buffer consisted of epsilon-aminocaproic acid (20 mmol/l) adjusted to pH 4.5 with acetic acid, negatively charged carboxyethyl-beta-cyclodextrin (2.5 mg/ml), serving as chiral selector, and 0.1% (w/v) methylhydroxyethylcellulose, serving as an electroosmotic flow suppressor. The proposed method was successfully validated appraising parameters of sensitivity, linearity, precision, accuracy/recovery and robustness and it is useful for routine use.

摘要

在具有抑制电渗流和紫外吸收光度检测的流体动力学封闭分离系统中,开发了环糊精介导的毛细管区带电泳法,用于高效分离和定量各种药物制剂(溶液、凝胶、胶囊)中的二甲茚定对映体。运行缓冲液由用乙酸调节至pH 4.5的ε-氨基己酸(20 mmol/l)、作为手性选择剂的带负电荷的羧乙基-β-环糊精(2.5 mg/ml)和作为电渗流抑制剂的0.1%(w/v)甲基羟乙基纤维素组成。该方法通过评估灵敏度、线性、精密度、准确度/回收率和稳健性等参数成功得到验证,可用于常规分析。

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