| 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。 |
| 关键词: 非布司他 液相色谱-质谱 有关物质 降解产物 |
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| Study on Degradation Products of Febuxostat by LC-MS |
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1.南京工业大学江苏省药物研究所，南京 210009；2南京工业大学药学院，南京 2118161,2
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1.Jiangsu Provincial Institute of Material Medica, Nanjing University of Technology, Nanjing 210009, China;2.School of Pharmaceutical Sciences, Nanjing University of Technology, Nanjing 211816, China
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| 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. |
| Key words: febuxostat LC-MS related substance degradation product |
