Development & Validation of RP-HPLC Method for the Estimation of Doravirine in Bulk and Pharmaceutical Dosage Form

A simple, accurate, rapid and precise isocratic reversed phase high-performance liquid chromatographic method has been developed and validated for determination of Doravirine in tablets. The chromatographic separation was carried out on Dionex C18 (250 x 4.6mm, 5µ) with a mixture of methanol: 0.05M potassium dihydrogen phosphate (40:60%v/v) as a mobile phase at a flow rate of 1.5 mL/min. UV detection was performed at 306 nm. The retention time was 5.24 min for Doravirine. Calibration plot was linear (r2=0.999) over the concentration range of 200-600 µg/mL. The method was validated for accuracy, precision, specificity, linearity, robustness, LOD and LOQ. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Doravirine in bulk and tablet dosage form.