Validation of a capillary electrophoresis method for the determination of cephradine and its related impurities

Abstract

A method validation is reported for the determination of the ß-lactamic antibiotic cephradine and its main impurity, cephalexin, by micellar electrokinetic chromatography (MEKC) with UV photometric detection. The validation was carried out in compliance with the analytical performance parameters required by the USP XXII. The capillary electrophoresis (CE) method was statistically compared with the HPLC method used in quality control laboratories; the analysis of variance showed no significant difference between the results obtained by the two methods, demonstrating CE to be a suitable alternative technique to HPLC in routine quality control. © 1995.