非布司他降解产物的LC-MS研究

    Study on Degradation Products of Febuxostat by LC-MS

    • 摘要: 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。

       

      Abstract: OBJECTIVE To investigate the degradation products of febuxostat. METHODS After forced degradation, products were determined by LC-MS. The structures of degradation products were elucidated by the results of mass spectrometry combined with the structure and the reaction mechanism. RESULTS It was speculated that the degradation products were 2-(3-cyano-4-isobutoxy-phenyl)-4-methyl-thiazole-5-carboxylic acid methyl ester, 2-(3-carbamoyl-4-isobutoxyphenyl)-4- methylthiazole-5-carboxylic acid, 2-(3-cyano-4-isobutoxy-phenyl)-4-methyl-1-oxidation thiazole -5-carboxylic acid methyl ester, a dimmer of febuxostat. CONCLUSION The method provides a reference of studying the stability of febuxostat and possible degradation pathway.

       

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