Analytical Method Development and Validation of Doravirine in Pharmaceutical Dosage Form by RP-HPLC

V. Hari Baskar*_, SK. Karishma
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur (V&P), Muthukur (M), SPSR Nellore–524346

ABSTRACT
A new method was established for estimation of Doravirine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Doravirine by using Agilent column (4.6×150mm) 5µ, flow rate was 1.0 ml/min, mobile phase ratio was Phosphate buffer: meoH (25:75% v/v), detection wavelength was 270 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.182mins. The % purity of Doravirine  was found to be 98.56%.The system suitability parameters for Doravirine such as theoretical plates and tailing factor were found to be 4343.2, 1.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)).
Keywords: Agilent column, Doravirine, RP-HPLC