DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF ELVITEGRAVIR IN PHARMACEUTICAL DOSAGE FORMS

The stability-indicating RP-HPLC method was developed and validated for quantitative determination of Elvitegravir in pharmaceutical dosage forms. An isocratic RP-HPLC method was developed with Luna C18 (250 mm x 4.6 mm, 5 µm) column and the mobile phase composed of 60 volumes of water and 40 volumes of acetonitrile mixture. The flow rate of the mobile phase was 1.2 mL min−1. Detection wavelength was 258 nm and ambient column temperature was maintained. The method was validated with regard to linearity, accuracy, precision, selectivity, and robustness. The drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation as per International Conference on Harmonization (ICH) prescribed stress conditions to show the stability-indicating power of the method.