苯甲酸阿格列汀的异构体控制方法

Isomer control method of Alogliptin benzoate

目的:探讨苯甲酸阿格列汀光学纯度与(R)-3-氨基哌啶双盐酸盐光学纯度之间的关系。方法:通过纯度测定方法检测(R)-3-氨基哌啶双盐酸盐的光学纯度,评价苯甲酸阿格列汀的光学纯度。结果与结论:(R)-3-氨基哌啶双盐酸盐光学纯度与苯甲酸阿格列汀之间的光学纯度有对应关系,通过控制(R)-3-氨基哌啶双盐酸盐光学纯度大于98%即可保证苯甲酸阿格列汀光学纯度合格。

Objective：To discuss the relationship of optical purity between alogliptin benzoate and （R）-3-amino piperidine double hydroehloride. Methods：By the optical purity determination method test （R）-3-amino piperidine double hydrochloride, evaluation of optical purity of alogliptin benzoate.Results and conclusion ：There is corresponding optical purity relationship of between alogliptin benzoate and （R）-3-amino piperidine double hydrochloride. By controlling the optical purity of （R）-3-amino piperidine double hydrochloride is more than 98% can be sure qualified the optical purity of alogliptin benzoate.