Advanced, Cutting-Edge RP-HPLC Methodology for the Comprehensive Quantitative Analysis of Assay of Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Co-Formulated Pharmaceutical Products.

Abstract

In the current study, a simple and economic stability-indicating RP-HPLC method development and validation was carried out to estimate the bictegravir, emtricitabine and tenofovir from the pharmaceutical dosage form. 0.1M ammonium acetate in 0.5% v/v acetic acid solution and 1g of 1-octane sulfonic acid and adjustment of pH to 4.2 with dilute orthophosphoric acid done and methanol (40:60 v/v) was utilized as the mobile phase. The analysis was done using Inertsil ODS 3V (250 x 4.6 mm x 5 µm) column with column temperature kept at 30°C with an injection volume of 20 μL, flow rate of 1.0 ml/ minute and detection was carried out at 260 nm. The method was developed and it was validated according to ICH Q2 (R1) guidelines. The RT of bictegravir, emtricitabine and tenofovir were determined to be 12.23, 3.0 and 8.5 minutes, providing a reliable marker for its identification. The method was found linear from about 50 To 150% Of the target concentration of bictegravir emtricitabine and tenofovir with of 0.999. Significant degradation was observed in acidic, basic and peroxide stress conditions. Hence, it can be concluded that tablets are sensitive to acidic, basic and oxidation stress conditions. RSD for the peak area responses of emtricitabine, 0.03 and 0.03, respectively, indicating that the system is precise. The testing procedure was accurate from about 50 to 150%. Of the target concentration of emtricitabine, tenofovir alafenamide and bictegravir. The method was robust In relation to flow variation, column oven temperature variation, mobile phase variation and pH variation. In conclusion, our proposed RP-HPLC method provides a sensitive, accurate, and precise means of analyzing emtricitabine, tenofovir alafenamide and bictegravir from pharmaceutical dosage forms.