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

doi:10.5246/jcps.2014.05.041

Journal of Chinese Pharmaceutical Sciences ›› 2014, Vol. 23 ›› Issue (5): 302-305.DOI: 10.5246/jcps.2014.05.041

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

Lipeng Sui, Ridong Li^*, Bo Song, Moyi Liu

R&D Center, China Resources Saike Pharmaceutical Co., Ltd., Beijing 101111, China

Received:2013-12-31 Revised:2014-02-26 Online:2014-05-23 Published:2014-03-10
Contact: Tel.: 86-10-57532555; E-mail: lrd0202@163.com

Abstract

Abstract:

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.

Key words: Azilsartan, Degradation, Impurities, Micronization

CLC Number:

R916.42

Supporting:

Lipeng Sui, Ridong Li, Bo Song, Moyi Liu. Characterization of two degradation products of Azilsartan formed during the micronization process and development of a method to control the degradation[J]. Journal of Chinese Pharmaceutical Sciences, 2014, 23(5): 302-305.

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

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