Development and Validation of LC-PDA Method for the Estimation of Doravirine and Related Impurities

The objective of the present research is to develop a reliable, sensitive, and robust stability-indicating RP-HPLC method to quantify doravirine along with its impurities (IMP-A, IMP-B). The separation was accomplished on a Inertsil ODS C18 (250 × 4.6 mm, 5 μm) column at 216 nm using 0.1% orthophosphoric acid and acetonitrile at a flow rate of 1 mL/min eluted with a retention time of IMP-A, IMP-B, and doravirine of 2.52 min, 3.96 min, and 8.74 min respectively. The optimized method was validated in terms of accuracy, precision, linearity, specificity, system suitability, and robustness as per International Council for Harmonization guidelines. The optimized method showed linearity within the concentration range 10–200 μg/mL, 0.7–14 μg/mL, and 0.5–10 μg/mL for doravirine, IMP-A, and IMP-B respectively. The method was found to be precise at %RSD < 2 and accurate with percentage recovery for doravirine, IMP-A, and IMP-B of 100.46%, 100.2%, and 99.2% respectively. The optimized method proved to be sensitive, robust, and specific. This optimized method can be routinely employed in quality control laboratories for the quantification of doravirine along with its impurities.