Synthesis of the Related Substances of Vildagliptin
Improved the synthesis method of vildagliptin impurity reference substance and conducted the quality control of vildagliptin.Two process impurities was synthesized according to the synthetic process of vildagliptin and three degradation impurities were synthesized according to the degradation pathway.The synthesis toward impurities relies only on recrystallization and does not need any column chromatography operation.The structures of the related substances of vildagliptin were verified by 1H NMR,13C NMR and MS(ESI).The purity of the five impurities was higher than 95％by HPLC so as to meet the requirement of impurities positioning and content calibration.The five impurities could be used as the impurity reference substance for the detection of related substance.
万方数据
维普
