Analyzing the Chiral Purity of Pharmaceuticals: The Application of Cyclodextrin-Based Chiral Selectors in Capillary Electrophoresis

Abstract

The current review provides a focused analysis of the application of capillary electrophoresis (CE) techniques to determine the chiral purity of pharmaceuticals, with a specific emphasis on cyclodextrin- (CD) based chiral selectors (CSs), highlighting advancements, methodologies, and trends in this area as reported in studies published from 2010 to 2024. The review emphasizes CE’s evolution as a critical tool in this field, discussing its advantages, such as high efficiency, flexibility, relatively low costs, and minimal environmental impact, which make it well-suited for modern pharmaceutical applications. Additionally, it underscores the importance of CE in meeting stringent regulatory requirements for chiral drug substances. A significant shift in method optimization has occurred in the last ten years, shifting from the traditional One-Factor-at-a-Time (OFAT) strategy to the Design-of-Experiments (DoE) approach; this shift has enabled more systematic and robust method development. Furthermore, a common trend in recent years is the application of Quality-by-Design (QbD) principles in method development and optimization, ensuring higher reliability and efficiency. Additionally, there is an increasing focus on developing CE methods capable of detecting both achiral and chiral impurities simultaneously, which enhances the comprehensiveness of the analysis. This review seeks to guide future research and development in optimizing CE methodologies for pharmaceutical applications.