Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF DARUNAVIR IN BULK AND DOSAGE FORM.

Kamlesh Valuba Bhuse* and Asst. Prof. Mrs. Jadhav P.B.

ABSTRACT

Background and objective: Objective of the present analytical research work was to developed and validate RP-HPLC method for the estimation Darunavir in bulk and dosage form. Method & Results: The RP-HPLC method for Darunavir was developed using column Phenomenex C18 column (5μm, 250mm × 4.6mm) as stationary phase and Acetonitrile : water (80:20 v/v) as mobile phase. The mobile phase was maintained at a flow rate of 1.0 ml/min and volume of injection is 1 μl detection was carried out at 267 nm. The method was validated in accordance with ICH guidelines. Darunavir were found to be linear in the concentration rang of 5, 10, 15, 20, 25, 30 and 35 μg/ml respectively. The result of % assay of marketed formulation was found as 99.15-101.88 % for Darunavir respectively. Accuracy of the method was determined by performing recovery study and the result were found in the range of 98-102 %w/w and for Darunavir respectively. % RSD of precision study of these drugs were found less than 2 % which indicated good precision of the developed method. Conclusion: The developed HPLC method was simple, rapid, easy, accurate and precise. So, the method can be applied successfully for the routine analysis of Darunavir in pharmaceutical industry.

Keywords: Darunavir, Acetonitrile, RP-HPLC, Method Development, Validation.