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

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.

Simultaneous Separation and Analysis of Five Compounds in Cibotium barometz by Micellar Electrokinetic Chromatography with Large-Volume Sample Stacking

“…The best peak a peak-to-peak resolution of the five compounds were obtained at 10 mM SDS, so SDS [30] was added to the buffer to improve the solubility of samples in the buffe In addition, since nonaqueous media can increase the solubility of hydropho pounds and also improve the selectivity [17], organic solvents are widely used in analysis. Thus, several types of organic solvents, such as methanol, acetonitrile a nol, were added to the buffer to investigate their influence on the separation e shown in Figure 3, when a constant concentration of 10% methanol was maint buffer, none of the analytes precipitated, and a stable current was obtained in the of electrophoretic separation [19].…”

“…Based on the concepts of positive environmental impact and health, capillary electrophoresis (CE) has versatility and high separation power, which can satisfy the quantitative separation and identification of traditional Chinese medicine [16,17]. However, the sensitivity and selectivity of CE are limited due to the small injection volume (nL range) [18] and short optical path length, which hamper the determination of low-concentration components [19]. Fortunately, it can be solved by special electrophoresis patterns (e.g., capillary zone electrophoresis and electrokinetic chromatography) and on-line enrichment sample stacking techniques (e.g., large-volume sample stacking (LVSS), field-amplified sample injection and sweeping) [20].…”

The Use of Dual Cyclodextrin Chiral Selector Systems in the Enantioseparation of Pharmaceuticals by Capillary Electrophoresis: An Overview

“…Also, CE is known for its "green" features by comparison with the more frequently used HPLC, as the use of organic solvents is minimum. Furthermore, in CE almost always a direct separation approach is used by simply adding the appropriate CSs into the background electrolyte (BGE) [10,11]. Another advantage is represented by the fact that in CE the migration order of the enantiomers can be reversed based on the nature and characteristics of the CSs, enabling a better understanding and a more practical use of the enantioseparation process [12].…”

Application of capillary electrophoresis‐nano‐electrospray ionization‐mass spectrometry for the determination of N‐nitrosodimethylamine in pharmaceuticals

“…In addition to LC and GC, CE constitutes a promising technique for quality control analyses of pharmaceuticals [22–27]. It offers a high separation efficiency, minuscule sample and reagents consumption, high throughput via automation and generally low requirements on a sample pretreatment, and easy coupling with a variety of detection techniques.…”