[Advances in application of capillary electrophoresis in pharmaceutical analysis]

Abstract

Capillary electrophoresis (CE) is mainly applied in pharmaceutical analysis. All CE separation modes and detection methods show their characteristics and application abilities in the separation and analysis of different drug samples. The present review provides a brief cross section of new advances in CE application in pharmaceutical analysis, including for small molecular drugs and related substances (including chiral drug separation), traditional Chinese medicine and natural products, in vivo pharmaceutical analysis, and biological product analysis. However, the research on physical and chemical constant determination, affinity capillary electrophoresis and binding constant research (drug and receptor interaction, etc.), clinical biomarker analysis, metabolomics, and microchip CE analysis are not included. According to traditional pharmaceutical analysis developments, the recent advances in CE in compliance with pharmaceutical analysis regulatory requirements include CE capacitively coupled contactless conductivity detection (C⁴D), improved detection sensitivity and precision, CE-sodium dodecyl sulfate (CE-SDS), imaged capillary isoelectric focusing (icIEF), antibody analysis, and so on. Combined with the references, this review also discusses the current requirements in the field of traditional pharmaceutical analysis, as well as the status, challenges and opportunities of CE in it. Some suggestions on CE application as a complementary analysis method for chemical drugs and traditional Chinese medicine analysis are put forward, and the characteristics and ability of CE in biological product analysis is expected to further development. The new development of CE-MS and improvement of CE repeatability may greatly expand the field of application of CE in the future. This review covers the improvements published between January 2017 and February 2020, as well as some important CE papers published in 2016.

Keywords: biological product analysis; capillary electrophoresis; method validation; pharmaceutical analysis; review; traditional Chinese medicine analysis.