Application of RP-HPLC Technique for development of Analytical method for Validation of Tenofovir disoproxil fumarate from Bulk drug and Dosage form

Abstract

A novel reverse phase liquid chromatographic method was developed and validated for estimation of tenofovir disoproxil fumarate, HIV infection drug used in the treatment of human immunodeficiency virus (HIV) Type-1 patients in its dosage form i.e. tablets. The reverse phase HPLC analysis was carried out on isocratic system. The column was Hypersil BDS C18 (150mm x 4.6mm, 5µm) with ambient temperature. The mobile phase consisted of buffer: methanol in proportion 90:10 % (v/v). The flow rate was maintained at 0.8 ml / min. The detection was carried out at wavelength 260 nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy and precision. The linear ranges were 50-150 µg/ml for tenofovir disoproxil fumarate. The accuracy and precision were found to be well within the acceptable limit. The method was successfully applied for determination Tenofovir disoproxil fumarate in dosage form with good recoveries.