DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ATAZANAVIR SULPHATE IN BULK AND TABLET DOSAGE FORM

Abstract

Two simple, accurate, precise and cost effective UV-Spectrophotometric methods have been developed for estimation of Atazanavir sulphate (ATV), an anti-HIV drug, in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength, 247nm. Method B is Area under Curve (AUC), in wavelength range of 240-254nm. The linear responses were observed in the range of 5- 40 μg/ml for both the methods, with the regression coefficient of 0.9996 and 0.9997 respectively. The accuracy of the methods was assessed by recovery studies and was found to be 100.56% and 100.86% respectively. The developed methods were validated for different parameters like linearity, accuracy (recovery), precision and specificity, as per the ICH Q2 R1 (International Conference for Harmonization) guidelines and were found to be satisfactory. These methods can be used for the determination of Atazanavir sulphate in bulk and formulation without interference of the excipients.