Isolation and Characterization of Forced Degradative Products of a Proton Pump Inhibitor Drug Ilaprazole by LC/MS Technique

RP Khimani and Dr P Kapupara

Abstract

The liquid Chromatography-Mass spectroscopy (LC-MS) method was developed for isolation and characterization of degradation products of a proton pump inhibitor drug Ilaprazole. The method for the same was developed on Shimadzu LC-8030 with PDA System and Zodiac CN C18, (250mm x 4.6mm, 5μm) column using isocratic elution of mobile phase. The experiment was focused on force degradation studies like (as suggested in ICH guidelines) acid degradation, base hydrolysis, oxidative effects, ultraviolet light effect and thermal stability. The retention time of drug was a minor change in various condition but it was easily characterized by their mass spectra. Various degradants were found in conditions like acidic, basic and oxidative degradation. The chemicals structures of the degradants were identified by using mass spectroscopic data.