Vol. 7, Issue 2, Part D (2025)

The simultaneous quantification of Lamivudine, Abacavir, and Dolutegravir in pharmaceutical dosage forms was accomplished through the development and validation of a straightforward, accurate, and stability-indicating UPLC approach. The chromatographic separation was accomplished with an Inertsil ODS C18 (250 × 4.6 mm, 5 µm) column with a mobile phase that contained 50:20:30% v/v/v phosphate buffer (pH 3.0), acetonitrile, and methanol at a flow rate of 1.0 mL/min. ICH requirements for system appropriateness, linearity, accuracy, precision, LOD, LOQ, robustness, and solution stability were followed in the validation of the method. Since all degradation peaks were clearly separated from the drug peaks with a suitable mass balance, forced degradation tests conducted in acidic, basic, oxidative, thermal, and photolytic environments verified that the approach is stability-indicating. Lamivudine, Abacavir, and Dolutegravir in combination pharmaceutical formulations can be routinely tested for stability and quality control using this established approach.