Characterization of Elvitegravir and Its Related Impurities Using ESI–LC–MS, NMR Techniques, Method Development and Validation of Its Related Substances by HPLC Method

Elvitegravir (ETV), drug substance, and its eleven process-related impurities have been identified and their structural identification study has been carried out with the aid of 1H, 13C NMR, and ESI–LC–MS spectroscopic techniques. Plausible fragments were also proposed for each impurity to ascertain its structure. Simple, facile, and selective, stability indicating, mass spectrometry compatible HPLC method has been developed and subsequently validated with the validation parameters of specificity, LOD, LOQ, precision at LOQ, linearity, accuracy at LOQ to 120