Isolation and Identification of forced degradation products of Februxostat

Abstract

Abstract The current study explains the acid degradation behaviour of febuxostat API, a non-purine xanthine oxidase inhibitor used to treat hyperuricemia. A degradation study was carried out as per ICH guidelines, while the study confirms that the febuxostat is largely stable in thermal, photolytic, oxidative, and basic hydrolytic conditions and labile in acid hydrolysis conditions. There were four different degradation products found during acid hydrolysis; of these, degradation products 2, 3, and 4 are new and have never been reported before, while degradation product 1 is well-known and has already been published. All these degradation products were identified using UPLC-MS analysis, purified by using preparative HPLC and characterized using HRMS and NMR techniques. The formed degradation products are by the hydrolysis of ester and cyano functional groups of the febuxostat molecule under acidic conditions. All degradation products structural characterization was carried out using nuclear magnetic resonance spectroscopy (NMR) and high-resolution mass spectrometry (HRMS).