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目的研究非布司他的降解产物。方法强制降解后以LC-MS测定,根据质谱测定结果结合结构及反应机制推测降解产物结构。结果推测降解产物为2-[3-氰基-4-(2-异丁氧基)苯基]-4-甲基噻唑-5-羧酸甲酯、2-[3-氨基甲酰基-4(2-异丁氧基-)苯基]-4-甲基噻唑-5-羧酸、2-[3-氰基-4-(2-异丁氧基)苯基]-4-甲基-1-氧化噻唑-5-羧酸甲酯以及非布司他的二聚体。结论该法为研究非布司他的稳定性及其可能的降解途径提供了参考。
Objective To study the degradation products of febuxostat. Method Forced degradation by LC-MS determination, according to mass spectrometry results combined with the structure and reaction mechanism to speculate degradation product structure. As a result, it was presumed that the degradation product was methyl 2- [3-cyano-4- (2-isobutoxy) phenyl] -4-methylthiazole-5-carboxylate, 2- [3-carbamoyl-4 (2-isobutoxy-) phenyl] -4- methylthiazole-5-carboxylic acid, 2- [3-cyano- 4- (2-isobutoxy) phenyl] -1-oxidothiazole-5-carboxylate and the dimer of febuxostat. Conclusion This method provides a reference for the study of the stability of febuxostat and its possible degradation pathways.