METHOD DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF DARUNAVIR IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

Two simple, precise and economical UV Spectrophotometric methods have been developed for the estimation of Darunavir ethanolate (DRV) in bulk and its pharmaceutical dosage form. Two methods were developed based on measurement of absorption at maximum wavelengths, for Method Ⅰ 272.1 nm and Method ⅠⅠ 272.4 nm. Linearity for detector response was observed in the concentration range of 2-10 μg/ml for the both methods. The developed methods were validated with respect to linearity, accuracy (recovery), precision and specificity. The accuracy of the methods was assessed by recovery studies and was found to be 98.3% and 99% for Method Ⅰ and Method ⅠⅠ respectively. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory. The proposed methods were successfully applied for the determination of DRV in pharmaceutical dosage form. Key words: Darunavir, UV Spectrophotometry, Absorbance maxima methods and Validation.