An Analytical Method Development and Validation for Simultaneous Estimation of Atazanavir and Ritonavir in Tablet Dosage Forms by Using UPLC.

The present work was undertaken with the aim to develop and validate a rapid and consistent UPLC method in which the peaks will be appear with short period of time as per ICH guidelines. The UPLC separation was achieved on a Symmetry C18 (2.1 x 50 mm, 1.7 m, Make: BEH) or equivalent in an isocratic mode. The mobile phase was composed of phosphate buffer (40%) [pH 2.5] and acetonitrile (60%). The flow rate was monitored at 0.25 ml per min. The wavelength selected for the detection was 249 nm. The run time was 4 min. The retention time found for Atazanavir and Ritonavir were 0.819 and 1.236 min. respectively. The % recovery was found 98.75 – 101.01 % for Atazanavir and 99.05 - 100.39 % for Ritonavir. The linearity was established in the range of 30 to 90 g/ml for Atazanavir and 10 to 30 g/ml for Ritonavir. The LOD found for Atazanavir and Ritonavir were 0.026 and 0.048 µg/ml respectively. The LOQ found for Atazanavir and Ritonavir were 0.096 and 0.15 µg/ml respectively. Overall the proposed method was found to be suitable, sensitive, reproducible, specific and accurate for the quantitative determination of the drug in tablet dosage form.