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  • Title: Identification of a new impurity in lisinopril.
    Author: Shinde V, Trivedi A, Upadhayay PR, Gupta NL, Kanase DG, Chikate R.
    Journal: J Pharm Biomed Anal; 2007 Jan 04; 43(1):381-6. PubMed ID: 16926080.
    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.
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