New Green Stability Indicating Rp-Hplc Method Development And Validation Of Fixed Drug Combination Of Emtricitabine, Tenofovir Alafenamide And Dolutegravir Sodium In Marketed Formulation By Gradient Elution Programme

Abstract

In this work, a new, sensitive and accurate RP-HPLC method for determining the Emtricitabine, Tenofovir Alafenamide, and Dolutegravir sodium used for the treatment of viral disease was developed and validated. Shimadzu, C18 (4.6 mm X 100mm, 3.0 µm) column was used for the separation. Gradient elution programme of the mobile phase is composed of a solution containing 20 mM potassium dihydrogen phosphate and methanol was used for separation. UV detector was used and detection was performed at 254nm. The method showed linearity across the concentration range. The method was validated and effectively useful for the commercial dosage forms of the combination drug. The method has been proven to be highly accurate, precise, and robust according to the statistical analysis. The greenness profiles of the developed HPLC method were evaluated by AGREE evaluation method. The findings indicated that the described method aligns with the principles of green analytical chemistry.