The Estimation of Darunavir in Tablet dosage form by RP-HPLC.

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Darunavir in tablet dosage form. A RP Inertsil ODS-3V C-18, 250x4.6 mm, 5!m partical size, with mobile phase consisting of 0.02M Dipotassium hydrogen orthophosphate +0.02M Potassium Dihydrogen orthophosphatein in water and Acetonitrile in the ratio of 40:60 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 265 nm. The retention time was 5.859 min. The detector response was linear in the concentration of 80–240μg/ml. The respective linear regression equation being Y= 44076.08X +726603. The limit of detection and limit of quantification was 0.1μg and 0.3μg/ml respectively. The percentage assay of Darunavir was 98.58%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Darunavir in bulk drug and in its pharmaceutical dosage form.