Analytical Method Development and Validation for Simultaneous Estimation of Cobicistat and Elvitegravir by Using RP-HPLC in Pure and Pharmaceutical Dosage Forms

A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Cobicistat and Elvetigravir in pharmaceutical Tablet dosage form. The mobile phase consisted of 75:25 % (v/v) of Methanol and 0.1% v/v orthophosphoric acid operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic separation of Cobicistat and Elvetigravir was performed on Agilent Zorbax C18 column (150 X 4.6 mm id, ODS 2.5μm). The wavelength of detection is 265 nm. The injection volume is 20μL. The retention time of Cobicistat and Elvetigravir are 2.13 ± 0.02 minutes and 3.87 ± 0.02 min respectively. The run time of analysis is 6 minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and specificity. The influences of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs were studied. Results indicated complete degradation in alkaline medium for Cobicistat and Elvetigravir. The proposed method has been successfully used for the estimation in tablet dosage forms.