Analysis of impurities in rifalazil

Author: Jing-Xia ZHANG ¹
Author Information

1. Chengdu University
Publication Type:Journal Article
Keywords: Analysis; Impurity; Rifalazil
From: Chinese Pharmaceutical Journal 2015;50(7):639-645
CountryChina
Language:Chinese
Abstract: OBJECTIVE: To analyze the impurities of rifalazil. METHODS: HPLC method was used for related substances, TLC was used to detect the side chain isobutyl piperazine residues, TLC was prepared and column chromatography was used to separate impurities; HPLC was combined with TLC and UV, MS, NMR and other analytical tools was used to speculate the impurity. RESULTS: Impurity 1M-1 was to be 2-amino-3-(tert-butyldimethylsilyloxy) phenol, impurity IM-2 was to be 25-deacetyl-27-demethoxy rifalazil, impurity IM-3 was to be 25-deacetyl-rifalazil, IM-4 was to be rifalazil byproduct of 29 carbon and 15 carbon fracture. CONCLUSION: The analysis of impurities in rifalazil products has important significance for the improvement of the production process of rifalazil.