An overview of method validation and system suitability aspects in capillary electrophoresis

Abstract

Although capillary electrophoresis (CE) methods have been included in some regulatory submissions, the formal requirements for validation of such methods are not well-defined or universally understood. This paper provides a general overview of the aspects of method performance which need to be considered during the validation of CE methods particularly emphasising areas of similarity with, and differences between, HPLC and CE. The individual aspects of method performance are reviewed and guidance given, with illustrative literature examples where possible, on how to carry out suitable validation studies. Performance criteria are also provided, wherever possible. In this way, a suggested validation approach for CE methods is presented, reflecting the similarity with that generally adopted for HPLC methods, but accommodating those aspects which are different for, or peculiar to, CE.