Abstract

STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF ATAZANAVIR SULPHATE IN BULK AND IN PHARMACEUTICAL DOSAGE FORM USING FT-IR AND UV- VISIBLE SPECTROPHOTOMETER

Shinde Yogesh B.*, Wadher Shailesh J. and Kalyankar Tukaram M.

ABSTRACT

A simple, sensitive, rugged, cost effective, effective UV-VIS and FT-IR spectrophotometric method for the estimation of atazanavir sulphate, an anti-HIV drug, in bulk and pharmaceutical dosage form method was developed and validated. The solvent for UV-Visible used was methanol and the λmax or the absorption maxima of the drug was found to be 249.6 nm. A linear response was observed in the range of 2-12 μg/ml with a regression coefficient of 0.999. For FT-IR spectroscopy solid-state samples were prepared by dilution in dry potassium bromide. A linear relationship for the carbamate peak area between 1750-1650 cm−1 was observed in the range of 1.0 – 6.0% w/w with good correlation coefficient of 0.9972. The method was then validated for different parameters as per the ICH (International Conference for Harmonization) guidelines. Atazanavir sulphate was subjected to stress degradation under different conditions recommended by ICH. The samples so generated were used for degradation studies using the developed method.

Keywords: Atazanavir sulphate, HIV, ?max, UV-Visible spectroscopy, FT-IR spectroscopy.