1Pharmaceutical Quality Assurance Department, B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India
2Amneal Pharmaceutical Pvt. Ltd., 1 New England Avenue, Piscataway, NJ, 07936, USA
This work was aimed to develop and validate simple, rapid and economical kinetic degradation method for the estimation of Darunavir ethanolate in bulk and tablet dosage form. The spectrum was determined at 267.40nm by using methanol as a solvent. The developed method was validated as per ICH guideline. Accuracy was obtained between 97.18 - 101.12%. LOD and LOQ was found to be 0.52μg/ml and 1.60μg/ml respectively. Darunavir ethanolate was subjected to acid, base, oxidation, photolytic and thermal degradation and the amount of degradation is in the range 10 - 40%. Results confirmed that this method can be employed for the estimation of Darunavir ethanolate in presence of its degradation product in tablet dosage form.
Darunavir ethanolate, Stress degradation, Kinetic study, UV-Spectrophotometry
