Abstract

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

Mr. Mondhe Chintaman Chhagan* and Asst. Prof. Mr. Dabhade P. S.

ABSTRACT

Background and objective: Objective of the present analytical research work was to developed and validate RP-HPLC method for the estimation of Atazanavir in bulk and dosage form. Method and Results: The RP-HPLC method for Atazanavir was developed using column Hexon C18 column (5μm, 250mm × 4.6mm) as stationary phase and Acetonitrile: Water adjusted (80;20 v/v) as mobile phase. The mobile phase was maintained at a flow rate of 0.9ml/min and volume of injection is 1 μl detection was carried out at 282 nm. The method was validated in accordance with ICH guidelines. Atazanavir were found to be linear in the concentration rang of 10, 20, 30, 40, 50, 60 μg/ml respectively. The result of % assay of marketed formulation was found as 99.15-101.88 % for Atazanavir respectively. Accuracy of the method was determined by performing recovery study and the result were found in the range of 98.01-101.50 %w/w and for Atazanavir 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 Atazanavir in pharmaceutical industry.

Keywords: Atazanavir, Acetonitrile, water, Method development, Validation.