Abstract

DEVELOPMENT AND VALIDATION OF RP–HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENOFOVIR DISPROXIL FUMARATE AND LAMIVUDINE IN COMBINED TABLET DOSAGE FORM

Neha R. Jaiswal*, Dr. S. P. Pawar, Dr. S. T. Patil.

ABSTRACT

A simple, specific, accurate and precise RP-HPLC method with UV detection has been developed for the simultaneous determination of Tenofovir Disproxil Fumarate and Lamivudine in combined Tablet dosage form. The RP-HPLC method was performed by reverse phase C18 column (Younglin (S.K) Gradient System UV (250mm x 4.6mm, 5μ). The sample was analysed using Methanol 80 ml and water 20ml (pH 2.5, 0.05 % OPA) as a mobile phase at a flow rate of 7.0ml/min and detection at 265nm. The retention time for tenofovir and lamivudine was found to be 3.4667 min and 5.1833 min respectively. The Tablet 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 the10-50 μg/mL for tenofovir and 10-50 μg/mL for lamivudine, respectively, and recoveries from combined Tablet dosage form were between 98 and 102%. The method can be used for routine of the quality control in pharmaceuticals.

Keywords: Tenofovir, Lamivudine, Validation, RP-HPLC.