Identification of a new impurity in lisinopril.
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.
Shinde
Vikas
V
Lupin Research Park, Survey No. 46A/47A, Nande Village, Pune 411042, India.
Trivedi
Anurag
A
Upadhayay
P R
PR
Gupta
N L
NL
Kanase
D G
DG
Chikate
Rajeev
R
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
D012996:Solutions; D000641:Ammonia; D017706:Lisinopril