MULTIDIMENSIONAL EVALUATION OF IMPURITY PROFILES FOR GENERIC CEPHALEXIN AND CEFACLOR ANTIBIOTICS

A multidimensional approach is described for characterizing impurities in samples of generic cefaclor and cephalexin antibiotics. High-perfo rmance liquid chromatography (HPLC) with gradient elution followed by photodiode array or mass spectrometric detection provides valuable inf ormation concerning the nature of impurities observed. Results are pre sented which demonstrate the utility of these techniques for identifyi ng impurities and distinguishing among process-related impurities, deg radation products and formulation excipients. Preparative HPLC isolati on and spectroscopic identification of some impurities is also describ ed.