Characterization of impurities in the bulk drug lisinopril by liquid chromatography/ion trap spectrometry.
- Author:
Pei-xi ZHU
1
;
Dan-hua WANG
;
Cui-rong SUN
;
Zhi-quan SHEN
Author Information
- Publication Type:Journal Article
- MeSH: Chromatography, High Pressure Liquid; methods; Drug Contamination; Lisinopril; analysis; Magnetic Resonance Spectroscopy; Spectrometry, Mass, Electrospray Ionization; methods
- From: Journal of Zhejiang University. Science. B 2008;9(5):385-390
- CountryChina
- Language:English
- Abstract: Two trace impurities in the bulk drug lisinopril were detected by means of high-performance liquid chromatography coupled with mass spectrometry (HPLC/MS) with a simple and sensitive method suitable for HPLC/MSn analysis. The fragmentation behavior of lisinopril and the impurities was investigated, and two unknown impurities were elucidated as 2-(6-amino-1-(1-carboxyethylamino)-1-oxohexan-2-ylamino)-4-phenylbutanoic acid and 6-amino-2-(1-carboxy-3-phenylpro-pylamino)-hexanoic acid on the basis of the multi-stage mass spectrometry and exact mass evidence. The proposed structures of the two unknown impurities were further confirmed by nuclear magnetic resonance (NMR) experiments after preparative isolation.
