Introduction: A simple and Rapid High Performance Liquid Chromatographic method was developed and validated for simultaneous estimation of lamivudine, tenofovir alafenamide and dolutegravir in their tablet dosage form. Method: The method was established using Agilent C18 (250 × 4.6 mm, i.d., 5 μm) column, a mobile phase consisting of 0.05M phosphate buffer pH 6.2 (solvent A) and acetonitrile (solvent B) 60:40 v/v at a flow rate of 1 mL/min with isocratic elution, injecting 10 µL sample into the chromatographic system. The eluted compounds were detected by using PDA Detector at a detection wavelength of 260 nm and the temperature was maintained at 30°C. Result: Retention times for the three compounds were found to be 3.09 min, 6.19 min and 9.61min for lamivudine, tenofovir alafenamide, and dolutegravir respectively. The linearity range was 10-80 µg/ml for three drugs with values of LOD found to be 0.56, 0.39µg, 1.35µg and LOQ were found to be 1.50µg, 0.99µg and 3.61 µg for lamivudine, tenofovir alafenamide and dolutegravir respectively which were linear enough showing correlation coefficient 0.999 in all the cases. Conclusion: The proposed method is therefore, suitable for the purpose in quality-control laboratories for quantitative analysis of the drugs individually and in the combined dosage form. The method was found to be as it is simple and rapid with tremendous precision and accuracy. The method can be used as a routine quality control method for triple combined dosage forms.

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A simple and rapid high performance liquid chromatographic method was developed and validated for simultaneous estimation of Emtricitabine(EMT), Rilpivirine (RPV), and Tenofovir alafenamide fumarate(TAF)in bulk active pharmaceutical ingredients & its tablet formulation. The method was established using Agilent C18 (250 × 4.6 mm, i.d., 5 μm) column, mobile phase consisting of 0.1%Formic acid: Acetonitrile (65:35%, v/v) at a flow rate of 1 mL/min with isocratic elution, injecting 20 µL sample into the chromatographic system. The eluted compounds were detected by using PDA detector at detection wavelength of 250 nm and temperature was maintained at 30 °C. Retention times of Reference Standard Emtricitabine, Rilpivirine, and Tenofovir alafenamide was found to be 2.90, 4.34, 6.58mins respectively. The calibration curve was plotted over the concentration range 4-20 g/mL for EMT, 2-10 g/mL of RPV and 1-5 g/mL of TAF.The recoveries for EMT, RPV and TAF were found to be 99.12, 99.38, and 99.18%, respectively. All the validation parameters results were obtained with in acceptance limit.Developed method was subjected to forced degradation studies under specified conditions, which meets the required criteria. The present method was specific, sensitive, reproducible, precise, rapid and simple.

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