Abstract
A stability-indicating reverse phase–high performance liquid chromatography (RP–HPLC) method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C18 column Phenomenix (250mm×4.6mm, 5μm) with a mobile phase consisting of 900mL of HPLC grade methanol and 100mL of water of HPLC grade. The pH was adjusted to 3.55 with acetic acid. The mobile phase was sonicated for 10min and filtered through a 0.45μm membrane filter at a flow rate of 0.5mL/min. The detection was carried out at 249nm and retention time of atazanavir sulfate was found to be 8.323min. Linearity was observed from 10 to 90μg/mL (coefficient of determination R2 was 0.999) with equation, y=23.427x+37.732. Atazanavir sulfate was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation, and the results showed that it was more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
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