Characterization of two degradation products of Azilsartan formed during the micronization process and development of a method to control the degradation

通过微粉化工艺获得的阿齐沙坦两个降解杂质的定性以及对此降解过程控制的方法(英文)

The degradation of Azilsartan in the micronization process was studied and a degradation control method was developed. In the micronization process of Azilsartan, two degradation products （DP-1 and DP-2） were detected by HPLC. DP-1 is a known impurity but DP-2 has not been reported before. The structures of the two degradation products were identified by NMR and MS analysis. The formation of DP- 1 and DP-2 can be controlled by changing the micronization process.

本文对阿齐沙坦微粉化工艺中的降解产物以及对降解过程的控制进行了研究。通过HPLC检测发现,原料药在微粉化过程中产生两个杂质DP-1和DP-2,其中DP-2尚未见文献报道。经核磁共振谱和质谱对两个杂质的结构进行了鉴定,同时可以通过改变微粉化工艺对两个杂质的产生进行控制。