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毛细管电泳法在药品质量控制分析中的应用:综述。

Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review.

机构信息

Institute of Analytical Chemistry, Czech Academy of Sciences, Brno, Czech Republic.

出版信息

Electrophoresis. 2021 Jan;42(1-2):19-37. doi: 10.1002/elps.202000185. Epub 2020 Sep 28.

Abstract

Capillary electrophoresis represents a promising technique in the field of pharmaceutical analysis. The presented review provides a summary of capillary electrophoretic methods suitable for routine quality control analyses of small molecule drugs published since 2015. In total, more than 80 discussed methods are sorted into three main sections according to the applied electroseparation modes (capillary zone electrophoresis, electrokinetic chromatography, and micellar, microemulsion, and liposome-electrokinetic chromatography) and further subsections according to the applied detection techniques (UV, capacitively coupled contactless conductivity detection, and mass spectrometry). Key parameters of the procedures are summarized in four concise tables. The presented applications cover analyses of active pharmaceutical ingredients and their related substances such as degradation products or enantiomeric impurities. The contribution of reported results to the current knowledge of separation science and general aspects of the practical applications of capillary electrophoretic methods are also discussed.

摘要

毛细管电泳在药物分析领域是一种很有前途的技术。本篇综述提供了自 2015 年以来发表的适合小分子药物常规质量控制分析的毛细管电泳方法的总结。总共,80 多种讨论方法根据应用的电动分离模式(毛细管区带电泳、电泳色谱和胶束、微乳液和脂质体电泳色谱)以及应用的检测技术(紫外、电容耦合非接触式传导检测和质谱)分为三个主要部分和进一步的小节。程序的关键参数总结在四个简洁的表格中。所呈现的应用涵盖了活性药物成分及其相关物质(如降解产物或对映体杂质)的分析。还讨论了报道结果对分离科学的当前知识和毛细管电泳方法实际应用的一般方面的贡献。

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