Characterization of a novel impurity in bulk drug of lisinopril by multidimensional NMR technique.
- Author:
Dan-hua WANG
1
;
Sai-feng PEI
;
Ming-hua ZHOU
;
Cui-rong SUN
;
Yuan-jiang PAN
Author Information
1. Department of Chemistry, Zhejiang University, Hangzhou 310027, China.
- Publication Type:Journal Article
- MeSH:
Butyrates;
analysis;
isolation & purification;
Drug Contamination;
Lisinopril;
analysis;
Magnetic Resonance Spectroscopy;
Models, Molecular
- From:
Journal of Zhejiang University. Science. B
2006;7(4):310-313
- CountryChina
- Language:English
-
Abstract:
During the routine impurity profile of lisinopril bulk drug by HPLC (high-performance liquid chromatography), a potential impurity was detected. Using multidimensional NMR (nuclear magnetic resonance) technique, the trace-level impurity was unambiguously identified to be 2-(-2-oxo-azocan-3-ylamino)-4-phenyl-butyric acid after isolation from lisinopril bulk drug by semi-preparative HPLC. Formation of the impurity was also discussed. To our knowledge, this is a novel impurity and not reported elsewhere.