Forced degradation studies on axitinib and characterization of its degradation products by liquid chromatography‐high resolution mass spectrometry and nuclear magnetic resonance spectroscopy along with its insilico toxicity assessment

Abstract

AbstractThe prime focus of the present study includes forced degradation studies on axitinib and the characterization of novel degradation products formed. As per International Council for Harmonisation guidelines, axitinib was exposed to harsher conditions such as acidic, alkali, oxidative, photolytic, and thermal conditions. Axitinib was found unstable upon exposure to oxidative and photolytic conditions, generating a total of four degradation products. Out of four degradation products, three are novel and were not reported in the literature. The degradation products formed were well separated by high‐performance liquid chromatography and characterized by liquid chromatography‐high resolution mass spectrometric studies. Further, their structures were confirmed by nuclear magnetic resonance spectroscopic studies. The possible degradation products were characterized as sulfoxide, sulfone, isomeric and dimer impurities. A detailed mechanistic explanation for the formation of degradation products along with its insilico toxicity prediction was laid out.