STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE, BICTEGRAVIR AND TENOFOVIR ALAFeNAMIDE

A simple, specific, precise and robust method for the estimation of emtricitabine, bictegravir and tenofovir alafenamide in the presence of impurities was developed and validated. The separation was performed on Aquity UPLC system with SB C8 50 x 2.1 mm, 1.7μ column under isocratic elution mode. The components were eluted using 0.01 N phosphate buffer and acetonitrile in the ratio of 50:50 V/V and detected at UV wavelength of 272 nm. The retention times were found to be 1.017 min, 1.484 min and 1.864 min for emtricitabine, bictegravir and tenofovir alafenamide, respectively. The developed method was validated as per ICH guidelines. The method was stable and specific and when the sample was stressed under different conditions (acid, base, peroxide, photolytic, neutral, no interference of degradants were observed.