A Stability Indicating Method Development and Validation for The Simultaneous Estimation of Emtricitabine, Tenofovir Alafenamide and Doultegravir in Pharmaceutical Formulation by Ultra Performance Liquid Chromatography

Abstract

A Precise, specific, linear, accurate and robust technique used to be developed for the simultaneous estimation of the, Emtricitabine, Tenofovir alafenamide and Doultegravir in pill dosage structure and Validated as per ICH Validation guidelines. Method was once optimised with the useful resource of Acquity BEH C18 125A° (100 × 2.1 mm, 1.7μ) column at a flow rate of 0.6ml/min, Mobile part was as soon as pH 3.8 Buffer, Methanol and Acetonitrile (50:40:10 respectively). The Column Oven temperature used to be maintained at 35°C and working wave dimension used to be selected at 274nm. The retention times of Emtricitabine, Tenofovir Alafenamide and Doultegravir have been determined to be 3.77, 6.34 and 7.67minutes respectively. The % RSD of the Emtricitabine, Tenofovir Alafenamide and Doultegravir had been and located to be 0.27%, 1.24% and 0.11% respectivelyIn Method precision Parameter, % Assay had been determined ninety five to 105.0% and p.c Recovery had been acquired as 98.9%, 100.4% and 100.0% for Emtricitabine, Tenofovir Alafenamide and Doultegravir respectively. Linearity was as soon as acquired as 0.999, 0.999 and 0.999 for Emtricitabine, Tenofovir Alafenamide and Doultegravir respectively. Analytical Range used to be determined from the linearity and accuracy for Emitricitabine used to be 50µg/mL to 150µg/mL, Tenofovir Alafenamide used to be as soon as 6.25µg/mL to 18.75µg/mL and Doultegravir was as soon as 12.5µg/mL to 37.5µg/mL.