CHROMATOGRAPHIC SEPARATION FOR CILAZAPRIL AND RELATED IMPURITIES DETERMINATION

Abstract

A simple and rapid reverse-phase high-performance liquid chromatographic (HPLC) method for the simultaneousseparation and determination of Cilazapril and its process-related impurities in bulk drugs has been developed. Fourprocess-related impurities of Cilazapril have been separated on an Inerstsil ODS-3V (C18) column and detected at 254 nmusing a photo diode array (PDA). This HPLC method was successfully applied to the analysis of Cilazapril bulk drug. Therecoveries of Cilazapril and process-related impurities were in the range of 92.86 – 106.23%, and found to be specific,precise and reliable for the determination of un-reacted raw materials, intermediates in the reaction mixtures and bulk drugs.