Stability Indicating RP–HPLC Method for The Estimation of Etravirine in Pure and Tablet Dosage Form

Abstract

A simple, fast and precise stability indicating RP – HPLC method was developed for the separation and quantification of Etravirine in pharmaceutical dosage form. The quantification was carried out using Universal C18 4.6X150mm, 5μm enhanced polar selectivity column and mobile phase comprised of 0.02M potassium dihydrogen phosphate & 0.003M di potassium hydrogen phosphate buffer pH adjusted to 3.5 with 0.1% orthophosphoric acid and acetonitrile in proportion of ratio 45:55 and degassed under ultrasonication. The flow rate was 1mL/min and the effluent was monitored at 285nm. The retention time of Etravirine was 4.547min. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Etravirine was in the range of 10 – 60 μg/mL. The average percentage recovery of Etravirine was 99.02% from the tablet formulation. The stability – indicating capability was established by forced degradation experiments. The proposed method is suitable for determination of Etravirine in pharmaceutical dosage form.