Author: Havale ShrikantHanumanthappa, N.V.Byakod,S.Venkat Rao, A. Phani Kumar, P.Ramesh Babu

DOI:

The Present research is directed towards the synthesis and Characterization of process related impurities appear in Lopinavir active pharmaceutical ingredient as per available pharmacopeias like E.P and USP drug substance monographs. In order to meet the stringent regulatory requirements, we have been synthesized total of seven pharmacopeia specified impurities and these are confirmed by their structural elucidation with the help of sophisticated analytical instruments of FT-IR, Mass, ¹H&¹³CNMR and those were validated with available RPHPLC method with respect to their corresponding retention factors.

Keywords: Lopinavir, Process Related, Impurities Synthesis as per USP, EP and Regulatory Authorities, Impurity B, C, D, F, G, I, Q