Abstract

DEVELOPMENT AND VALIDATION OF SIMULTANEOUS RP-HPLC METHOD FOR ESTIMATION OF TENOFOVIR AND LAMIVUDINE IN BULK AND PHARMACEUTICAL FORMULATIONS

Ashwini S. Mali*, P. A. Salunke, S.D.Barhate, M.M.Bari

Abstract

A simple, specific, accurate and precise RP-HPLC method has been developed for the simultaneous determination of Tenofovir and Lamivudine from combined dosage form by reverse phase C18 column (Younglin ( S.K) Gradient System UV (250mm x 4.6mm) 5μ). The sample was analysed using Acetonitrile 80 ml and water 20ml( pH 6.2 ,0.05 % OPA) as a mobile phase at a flow rate of 1.0ml/min and detection at 260nm. The retention time for tenofovir and lamivudine was found to be 2.933 min and 6.966 min respectively. The stability assay was performed for this combination and was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the5-25 μg/mL for tenofovir and 5-25 μg/mL for lamivudine, respectively, and recoveries from combined dosage form were between 98 and 102%. The method can be used for estimation of combination of these drugs in combined dosage form.

Keywords: Tenofovir , Lamivudine , RP-HPLC