Research Article
Jahnavi Bandla, S. Ganapaty, G
Abstract
A simple, precise, accurate, stability indicating method was developed for the estimation of Atazanavir sulfate in bulk drug and pharmaceutical dosage form by RP-HPLC. The separation was done using inertsil C-18 (250mm × 4.6mm, 5μ) column at a flow rate of 1mL/min with a column temperature of 30ºC on an isocratic mode. The detection wavelength used is 248nm. The mobile phase used is potassium dihydrogen phosphate (0.01N) and acetonitrile in the ratio of 55:45 (v/v). The performance of the method was validated according to the ICH guidelines for specificity, linearity, accuracy, precision, ruggedness and robustness. The retention time for Atazanavir sulfate was found to be 2.56mins. A good linear response was observed in the concentration range of 25μg/mL to 150μg/mL, with a correlation coefficient of 0.999. Atazanavir sulfate was subjected to stress conditions including acidic, alkaline, oxidation, neutral degradation, thermal degradation and photolysis, and the net degradation was found to be within the limits.