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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 C(31)H(41)N(3)O(7). The impurity was isolated by preparative HPLC utilizing a linear gradient of water and acetonitrile. The structural analysis of the isolated product by (1)H, (13)C NMR, mass spectroscopy and FT-IR revealed it to be a 4-phenyl butanoic acid derivative (CL) of lisinopril.[1]

References

  1. Identification of a new impurity in lisinopril. Shinde, V., Trivedi, A., Upadhayay, P.R., Gupta, N.L., Kanase, D.G., Chikate, R. Journal of pharmaceutical and biomedical analysis (2007) [Pubmed]
 
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