T. Hanuman, Dr. T. Sivakkumar, Dr. S. Sridhar
A simple, Précise, Accurate method was developed for the estimation of Doravirineby RP-HPLC technique. Chromatographic conditions used are stationary phase Agilent C18 (250mm X 4.6mm5), Mobile phase0.01N KH2PO4: Methanol in the ratio of 50:50 and flow rate was maintained at 1.0ml/min, detection wave length was 210nm, column temperature was set to 30oC and diluent was mobile phase conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between25% to150 % levels, R2 value was found to be as 0.999.LOD and LOQ are 0.20µg/ml and 0.61µg/ml respectively. By using above method assay of marketed formulation was carried out 99.98% was present. Degradation studies of Doravirine were done, in all conditions purity threshold was more than purity angle and within the acceptable range.This method can be used for routine analysis of Doravirine. Key words: HPLC Doravirine, Method development. ICH Guidelines.