A comprehensive forced degradation studies of Cariprazine hydrochloride using LC-HRMS/MS and in silico toxicity predictions of its degradation products

Abstract

Cariprazine hydrochloride is a second-generation antipsychotic drug and has been approved by the US Food and Drug Administration and the European Medicines Agency. Herein, we have reported a stability-indicating assay method for the Cariprazine hydrochloride and characterization of its major degradation products using LCHRMS/ MS. The drug substance Cariprazine hydrochloride was subjected to acid, base, oxidation, thermal and photolytic stress degradation.