Use of a Single Capillary Electrophoresis Method as a Routine Identity Test for Batch Release of a Range of Pharmaceutical Products

Two independent and orthogonal analytical methods are required when performing identity testing of pharmaceutical products during routine release testing. A microemulsion electrokinetic chromatography method has been developed and validated for routine use as an identity test to release various pharmaceutical products including tablets, capsules and creams. Implementation of the method involved optimisation of parameters to achieve reliable routine operation. Rinsing procedures, in particular, were found to be essential to obtain consistent profiles and migration times. The method has replaced, and offers the potential to replace, a number of methods including HPLC and IR due to the considerable cost and time savings obtained through its use. This method has been successfully approved by the US FDA as a part of 2 New Drug Applications, is registered in Japan, and is in routine QA use within a factory environment.