The Validation of a Simple, Robust, Stability-Indicating RP-HPLC Method for the Simultaneous Detection of Lamivudine, Tenofovir Disoproxil Fumarate, and Dolutegravir Sodium in Bulk Material and Pharmaceutical Formulations.

An effective analytical method is requisite to ensure the accurate identification and quantification of drug(s), either in bulk material or in complex matrices, which form part of finished pharmaceutical products. For the purpose of a pharmaceutical formulation study, it became necessary to have a simple, yet robust and reproducible reversed-phase HPLC method for the simultaneous detection and quantification of lamivudine (3TC), tenofovir disoproxil fumarate (TDF), and dolutegravir sodium (DTG) in bulk form, complex polymeric matrices, and during drug release studies. A suitable method was developed using a Kinetex® C, 250 × 4.