毛细管电泳在药物分析中的可能性与局限性。

Possibilities and limitations of capillary electropherosis in pharmaceutical analysis.

作者信息

Borst C, Belal F, Holzgrabe U

机构信息

Institute of Pharmacy and Food Chemistry, University of Würzburg, Germany.

出版信息

Pharmazie. 2013 Jul;68(7):526-30.

PMID:23923632

Abstract

Capillary electropherosis (CE) has been proved to be an important alternative to high-performance liquid chromatography (HPLC) in pharmaceutical analysis. However, when it comes to the analysis of compounds, e.g. impurities or metabolites, of very different polarity and water solubility CE and the related techniques come to its limits. This is demonstrated for the antipsychotic drug quetiapine and its impurities. A nonaqueous capillary electrophoresis (NACE) method was developed using a background electrolyte (BGE) composed of ammonium acetate dissolved in a mixture of acetonitrile and methanol including acetic acid to protonate the substances. The NACE method gave an excellent separation of all components. Since the conductivity of the BGE used in the NACE method is quite low and problems with current occurred, an additional aqueous capillary zone electrophoresis (CZE) method was developed for quetiapine and the two water soluble derivatives, using phosphate buffer as BGE. The method was validated with regard to repeatability and limit of detection.

摘要

在药物分析中，毛细管电泳（CE）已被证明是高效液相色谱（HPLC）的一种重要替代方法。然而，在分析极性和水溶性差异很大的化合物（如杂质或代谢物）时，CE及相关技术就会受到限制。抗精神病药物喹硫平及其杂质的分析就证明了这一点。开发了一种非水毛细管电泳（NACE）方法，使用由溶解在乙腈和甲醇混合物中的醋酸铵组成的背景电解质（BGE），并加入醋酸以使物质质子化。该NACE方法能出色地分离所有组分。由于NACE方法中使用的BGE的电导率相当低且出现了电流问题，因此针对喹硫平和两种水溶性衍生物开发了一种额外的毛细管区带电泳（CZE）方法，使用磷酸盐缓冲液作为BGE。该方法在重复性和检测限方面得到了验证。