Reversed-phase liquid chromatography with mass and NMR characterization of forced degradation relate

来源 :43rd International Symposium on High Performance Liquid Phas | 被引量 : 0次 | 上传用户:cxdyc666
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A stability indicating reversed phase liquid chromatographic mass spectrometric method was developed and validated for the determination of forced degradants of Sitagliptin in bulk drugs.Sitagliptin was subjected to acid,alkaline hydrolysis,H2O2 oxidation,photolysis,and thermal stress.Significant degradation was observed during acid hydrolysis and the degradants were isolated on a mass based purification system and characterized by high-resolution mass spectrometry,and 1H 13C NMR spectroscopy.Mass and NMR revealed the possible structures of degradants under stress conditions.
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