Development and Validation of Discriminative Dissolution Test for Tenofovir Disoproxil Fumarate Formulation

Abstract

Objectives and Introduction: This study uses HPLC and UV spectrophotometric methods to develop and validate a discriminative dissolution test method for quality control of tenofovir disoproxil fumarate in a tablet. Tenofovir disoproxil fumarate is a drug used in combination therapy to treat HIV infection. It has antiviral, prodrug, and HIV-1 reverse transcriptase inhibitory properties.Materials and Methods: Phosphate buffer 6.8, water, and 0.01 N HCl were the components of the discriminative solution. The USP Apparatus II blade should be used at 75 rpm and 900 mL of 0.01 N HCl at 37º±0.5ºC for the best dissolving. Tenofovir disoproxil fumarate's in vitro release profiles perform well under these circumstances. This was done on Agilent ZORBAX C8 a 6x150 mm column, the temperature of the column was ambient, its flow rate was 1.0 mL/ min and the detection wavelength was 260 nm. The mobile phase comprised of 70:30 v/v mixture of methanol and formic acid solution.Results: When the conditions were optimal, this approach demonstrated good release. Method validation was carried out as per the ICH guidelines. The drug follows zero-order release kinetics.Conclusion: The results obtained by the proposed method for dissolution test for Tenofovir disoproxil fumarate tablet formulation were found to be reliable, rugged, linear, accurate and precise.

Keywords: Discriminative dissolution; Dissolution test; HPLC; Tenofovir disoproxil fumarate