Eco-Friendly Stability-Indicating RP-HPLC Method for Estimation of Dolutegravir in Pharmaceutical Formulation

The present investigation focuses on the degradation characteristics of dolutegravir, particularly in its solution phase. The study design encompasses the selection of a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of the drug, followed by an assessment of degradation and validation of the proposed analytical approach. The Shimadzu HPLC series 1100 was employed for the stress degradation assessment of dolutegravir in tablet formulation. The analytical procedure utilised an Agilent ZORBAX SB-C8 column (4.6×150×5 μm) along with a mobile phase composed of acetonitrile and phosphate buffer in a 60:40 ratio; the wavelength selected for analysis was 257 nm with a flow rate of 1 mL/min, at which the drug exhibited a distinct peak. The analysis was conducted in isocratic pump mode with an injection volume of 20 μL. Dimethylformamide was used as the diluent. The proposed methodology demonstrated linearity within the concentration range of 5 to 30 μg/mL. The analysis involved the placement of standards and samples in acidic, alkaline, oxidative, neutral, and thermal hydrolytic solutions within an oven at 50ºC and at ambient temperature for a duration of 180 minutes for the samples. The findings indicated that temperature, acidity, and oxidative conditions significantly affect the stability of dolutegravir, which was determined to be most stable under alkaline conditions and at lower temperature settings. The proposed methodology was assessed to be accurate, precise, robust, environmentally friendly, and effectively employ for the assay, degradation (stress testing), and forced degradation of the drug.