DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLET DOSAGE FORM
Keywords:
Darunavir ethanolate (DRV), UV Spectrophotometry, Absorbance maxima method, Area under curveAbstract
Two simple, precise and economical UV methods have been developed for the estimation of Darunavir ethanolate (DRV) in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength, 266 nm. Method B is area under curve (AUC), in the wavelength range of 255-275 nm. Linearity for detector response was observed in the concentration range of 3-18 μg/ml for the both methods. The developed method was 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 100.07% and 99.58% for Method A and Method B 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 tablet dosage form.
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References
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