Identification of the related substances in bendamustine hydrochloride
10.11665/j.issn.1000-5048.20150312
- VernacularTitle:盐酸苯达莫司汀有关物质结构鉴定
- Author:
Wenhua CHEN
1
;
Limin ZOU
;
Fei ZHANG
;
Liandi ZHANG
;
Mingyi LIAO
;
Li DING
Author Information
1. 中国药科大学药物分析教研室；江苏先声药业有限公司
- Publication Type:Journal Article
- Keywords:
bendamustine hydrochloride;
related substances;
structural identification;
content determination
- From:
Journal of China Pharmaceutical University
2015;46(3):333-338
- CountryChina
- Language:Chinese
-
Abstract:
In the HPLC analysis of bendamustine hydrochloride, two related substances(IMP01 and IMP02)were detected. These two related substances were identified by LC-MS/MS and their structural confirmation was unambiguously carried out by synthesis followed by characterization using Q-TOF/MS and NMR. Based on the spectral data, related substances IMP01 and IMP02 were characterized as 4-(1-methyl-5-morpholino-1H-benzo［d］imidazol-2-yl)butyric acid hydrochloride and 4-{1-methyl-5-［(2-chloroethyl)(2-hydroxyethyl)amino］-1H-benzo［d］imidazol-2-yl)} butyric acid hydrochloride, respectively. Bendamustine hydrochloride and its related substances were separated under the established LC-MS condition. HPLC is a useful method for the determination of the related substances in bendamustine hydrochloride. Results obtained are valuable for its manufacturing process and quality control.
