Impurity profile study of raloxifene hydrochloride
- Author:
Xian ZHAO
1
Author Information
- Publication Type:Journal Article
- Keywords: Fragmentation pattern; HPLC-IT-TOF-MS; Impurity profile; Quality control; Raloxifene
- From: Chinese Pharmaceutical Journal 2016;51(16):1423-1428
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To investigate the impurity profile of raloxifene thus to lay a foundation for the establishment of drug quality standard. METHODS: HPLC-IT-TOF-MS was adopted to analyze destroyed raloxifene and reference substances of impurities. According to the mass spectrometry fragmentation patterns of known impurities, the structures of unknown impurities were speculated. RESULTS: Destroyed raloxifene totally produced three impurities, one of which was unknown. Based on the regular mass spectrometry fragmentation patterns of raloxifene and known impurities, the unknown impurity was speculated to be a sulfone that was generated through further oxidation of raloxifene. CONCLUSION: The methods and results of this study could lay a foundation for the impurity control during production and in vivo analysis of raloxifene.
