Development and Validation of RP-HPLC Method for the Quantification of Doravirine in Bulk and Tablet Formulation

A novel RP-HPLC method was established for quantifying Doravirine and its tablet formulation. The chromatographic conditions were optimized to effectively separate Doravirine using a Shim-Pack Solar C₁₈ column (4.6x250mm) with a 5µm particle size. The flow rate was maintained at 1.0ml/min, and the mobile phase was a 60:40% v/v mixture of acetonitrile and water. Doravirine detection occurred at 324 nm. The HPLC system included a Shimadzu HPLC Auto Sampler, a DGU-20A5R separation module, a photodiode array detector, and lab solution software. Doravirine had a retention time of 4.920 minutes and a purity of 98.56%. System suitability parameters, such as theoretical plates (5349) and tailing factor (1.142), were evaluated. The method was validated according to ICH guideline Q2(R1) for accuracy, precision, specificity, linearity, and robustness, and to determine the limits of detection (LOD) and quantification (LOQ). The method proved to be simple, accurate, rapid, and precise for assessing Doravirine and its formulation.