Identification of impurity profile in tinidazole glucose injection by UPLC-MS
10.16438/j.0513-4870.2019-0278
- VernacularTitle:替硝唑葡萄糖注射液杂质的色谱-质谱结构鉴定
- Author:
Jing-jing WANG
1
;
Wei-feng DU
2
;
Xing-hong WEI
2
;
Zi-li XIE
2
;
Jie CHENG
2
Author Information
1. Anhui University of Chinese Medicine, Hefei 230038, China
2. Anhui Institute for Food and Drug Control, Hefei 230051, China
- Publication Type:Research Article
- Keywords:
tinidazole and glucose injection;
organic impurity;
UPLC-MS;
structure identification
- From:
Acta Pharmaceutica Sinica
2019;54(9):1655-1660
- CountryChina
- Language:Chinese
-
Abstract:
Five components in the impurity profile of tinidazole glucose injection were detected and identified by UPLC-Q Exactive quadrupole-electrostatic field orbitrap high resolution mass spectrometry, in combination with retention time references, organic reaction mechanisms and UV spectral analysis. They are 2-methyl-5-nitroimidazole (impurity 1), 5-hydroxymethylfurfural (impurity 2), 1-(2-(ethylsulfonyl)ethyl)-2-methyl-4-nitro-1H-Imidazole (impurity 5), 1-(2-(ethylthio)ethyl)-2-methyl-5-nitro-1H-imidazole (impurity 6) and 1,4-di-N-oxo-2-methyl-5-nitro-1H-imidazole (impurity 8) respectively, of which impurities 6 and 8 are identified for the first time. These results and detection methods are useful for monitoring the manufacturing process and quality control of tinidazole and glucose injection solution.
