RESUMO
Objective To optimize the process of vildagliptin based on the principle of quality by design(QBD),so as to con?trol the safety and quality of the product. Methods Process route was confirmed through investigating literature and the advantages or disadvantages of each route were discussed. The key process parameters were determined according to the single factor experiments , which were designed by understanding of product process and process controls. Meanwhile,impurities of intermediates were studied and the safety and quality of the product could be guaranteed. Results and Conclusion Industrial process of vildagliptin was devel?oped by the principle of QBD,which can promise the safety and quality of vildagliptin,improve product quality and meet the registra?tion requirements of State Food and Drug Administration(SFDA).