AN OVERVIEW OF METHOD VALIDATION AND SYSTEM SUITABILITY ASPECTS IN CAPILLARY ELECTROPHORESIS

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 pap er provides a general overview of the aspects of method performance wh ich need to be considered during the validation of CE methods particul arly emphasising areas of similarity with, and differences between, HP LC and CE. The individual aspects of method performance are reviewed a nd guidance given, with illustrative literature examples where possibl e, on how to carry out suitable validation studies. Performance criter ia are also provided, wherever possible. In this way, a suggested vali dation 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.