A new Stability-indicating UHPLC for the simultaneous determination of a combination of Anti-viral drugs: Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate

Abstract

Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate are anti-viral drugs. A new stability indicating UHPLC method has been proposed for the simultaneous determination of Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate tablets on gradient mode with 1.0mL/min flow rate and a diluent consisting of a mixture of phosphate buffer (pH 3.0) and acetonitrile (62: 38) was used for the study. Shimadzu NexeraX2 Model UPLC system with (PDA detector) Zorbax SB-C18 column (100mm × 4.60mm, 3.5μ) was employed for the present study. Beer-Lambert’s law was obeyed over the concentration range 5-900, 2-700 and 2-150µg/mL with linear regression equationsy = 1724.x-11307 (R² = 0.999), y = 1737.x-1009 (R² = 0.999) and y = 3538.x+587.5 (R² = 0.999) for Lamivudine, Tenofovir disoproxil fumarate and Dolutegravir sodium and the method was validated as per ICH guidelines. The LOQ values were found to be 4.4926, 1.8342 and 1.7963 µg/mL and that of LOD values as 1.4811. 0.6024 and 0.5903µg/mL forD Lamivudine, Tenofovir disoproxil fumarate and Dolutegravir sodium respectively. The combination of Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate was exposed to various stress conditions and the stability of the proposed method was carried out at UV detection 260nm. The proposed UHPLC method is simple, precise, accurate, robust and used for the routine analysis of tablet dosage forms.