title: Identification of a new impurity in lisinopril.
abstract: LC-UV scan of lisinopril revealed the presence of an unknown impurity (approximately 0.14%) at a relative retention time of 3.26 employing phosphate buffer-acetonitrile as binary gradient system while LC-MS analysis with binary gradient system comprising of a ammonia-ammonium acetate buffer (pH 5.0) and acetonitrile indicated it to be C31H41N3O7. The impurity was isolated by preparative HPLC utilizing a linear gradient of water and acetonitrile. The structural analysis of the isolated product by 1H, 13C NMR, mass spectroscopy and FT-IR revealed it to be a 4-phenyl butanoic acid derivative (CL) of lisinopril.
authors.affiliation: Lupin Research Park, Survey No. 46A/47A, Nande Village, Pune 411042, India.
authors.forename: Vikas
authors.initials: V
authors.lastname: Shinde
authors.forename: Anurag
authors.initials: A
authors.lastname: Trivedi
authors.forename: P R
authors.initials: PR
authors.lastname: Upadhayay
authors.forename: N L
authors.initials: NL
authors.lastname: Gupta
authors.forename: D G
authors.initials: DG
authors.lastname: Kanase
authors.forename: Rajeev
authors.initials: R
authors.lastname: Chikate
mesh_terms: D000641:Ammonia / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D008401:Gas Chromatography-Mass Spectrometry; D017706:Lisinopril / Q000032:analysis*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D017550:Spectroscopy, Fourier Transform Infrared
chemical_list: D012996:Solutions; D000641:Ammonia; D017706:Lisinopril