Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TENOFOVIR IN BULK AND TABLET DOSAGE FORMS

Shaik Rafiya*, Sayyada Saleha, Momina, Shaik Shaheen, Thanda Madhavi

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Abstract

The present research study accurate and precise stability indicating RPHPLC method has been developed for the validation of Tenofovir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Kromasil C18 (4.6×250mm, 5μ) column using a mixture of Methanol: Water (70: 30% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the The separation achieved at 267 nm. The retention time was found 3.475 minutes. The method produce linear responses in the concentration range of 10-60 μg/mL of Tenofovir. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Tenofovir; RP-HPLC; Validation; Tablet dosage forms.