Identification of Crizotinib Major Degradation Products Obtained Under Stress Conditions by RP-UHPLC-HRMS

The pharmaceutical industry routinely performs stability testing on new compounds before they are marketed to ensure their efficacy, quality, and safety.The focus of this study was to apply forced degradation as one of the stability testing methods to investigate the stability of crizotinib, an anticancer drug, and to gain insight into the degradation pathway and degradation products formed.The forced degradation study for crizotinib was performed under acidic and alkaline hydrolysis, oxidation, photolysis and thermal conditions.Drug degradation was observed under oxidative conditions.The structures of the three major degradation products formed by oxidative degradation were identified and characterized by UHPLC/QTOF/MS/MS studies and their possible fragmentation pathways were suggested.The toxicity evaluation of the tested compound and its proposed degradation products was also estimated using the computer program TEST (Toxicity Estimation Software Tool).