Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications

This review is in support of the development of selective, reproducible and validated capillary electrophoretis (CE) methods. Focusing on pharmaceutic al and biological applications, the successful use of CE is demonstrated by more than 800 references, mainly from 1994 until 1998. Approximately 80 re cent reviews have been catalogued. These articles sum up the existing strat egies for method development in CE, especially in the search for generally accepted concepts, but also looking for new, promising reagents and ideas. General strategies for method development were derived not only with regard to selectivity and efficiency, but also with regard to precision, short an alysis time, limit of detection, sample pretreatment requirements and valid ation. Standard buffer recipes, surfactants used in micellar electrokinetic capillary chromatography (MEKC), chiral selectors, useful buffer additives , polymeric separation media, electroosmotic flow (EOF) modifiers, dynamic and permanent coatings, actions to deal with complex matrices and aspects o f validation are collected in 20 tables. Detailed schemes for the developme nt of MEKC methods and chiral separations, for optimizing separation effici ency, means of troubleshooting, and other important information for key dec isions during method development are given in 19 diagrams. Method developme nt for peptide and protein separations, possibilities to influence the EOF and how to stabilize it, as well as indirect detection are considered in sp ecial sections.