Identification of the related substances in bendamustine hydrochloride / 中国药科大学学报
Journal of China Pharmaceutical University
; (6): 333-338, 2015.
Article
in Zh
| WPRIM
| ID: wpr-811954
Responsible library:
WPRO
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.
Full text:
1
Database:
WPRIM
Type of study:
Diagnostic_studies
Language:
Zh
Journal:
Journal of China Pharmaceutical University
Year:
2015
Document type:
Article