A NEW SIMPLE ANALYTICAL REVERSE PHASE RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DORAVIRINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

An efficient and simple RP-HPLC method has been developed and validated for the estimation of Doravirine in bulk and marketed pharmaceutical dosage forms. The mobile phase used for the chromatographic runs consisted of Methanol and Phosphate buffer (0.02M, pH-3.6) in the ratio of 40:60% v/v. The separation was achieved on an Inertsil C18 ODS (4.6mm × 250mm) 5µm particle size column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 246 nm. The retention time of Doravirine was found to be 5.493minutes. The method was linear at the concentration range 6–14 μg/ml for Doravirine. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Doravirine limit of detection (LOD) and limit of quantification (LOQ) were 0.487μg/ml and 1.477μg/ml respectively. Keywords: Doravirine, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.