Characterization of a novel impurity in bulk drug of lisinopril by multidimensional NMR technique.
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.
Department of Chemistry, Zhejiang University, Hangzhou 310027, China.
Dan-hua
DH
Wang
Sai-feng
SF
Pei
Ming-hua
MH
Zhou
Cui-rong
CR
Sun
Yuan-jiang
YJ
Pan
D002087:Butyrates / Q000032:analysis* / Q000302:isolation & purification; D004340:Drug Contamination; D017706:Lisinopril / Q000032:analysis*; D009682:Magnetic Resonance Spectroscopy; D008958:Models, Molecular
D002087:Butyrates; D017706:Lisinopril