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Characterization of a novel impurity in bulk drug of lisinopril by multidimensional NMR technique.

Wang DH, Pei SF, Zhou MH, Sun CR, Pan YJ

Department of Chemistry, Zhejiang University, Hangzhou 310027, China.

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.

Published 13 March 2006 in J Zhejiang Univ Sci B, 7(4): 310-3.
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