Validation des méthodes d'électrophorèse capillaire appliquées à l'analyse des composés pharmaceutiques

Abstract

Guidelines are given on how to carry out valida- tion for methods using capillary electrophoresis in pharmaceutical analysis. The similarities and differences with that of method validation in high performance liquid chromatography are outlined. The different validation criteria are successively examined and illustrated with examples issued from the different application areas of capillary electrophoresis in the pharmaceutical industry : assay of a main component, determination of impurities, chiral separations and small ions analysis.