A Simple Validated UV Spectrophotometric Method for the Estimation of Tenofovir disoproxil fumarate in bulk and Pharmaceutical dosage form

Abstract

A simple, accurate, rapid and sensitive UV spectrophotometric method has been developed for the estimation of Tenofovir disoproxil fumarate (TDF) in bulk as well as in Pharmaceutical dosage form. TDF is used as antiretro-viral agent. The present research work involves the estimation of TDF using methanol as solvent. An absorption maximum (λ max) was found to be 259.5 nm. It obeys the beer's law in the concentration range of 550 μg/ml with a correlation coefficient value of 0.9998. Validation of the method has been carried out statistically as per ICH guidelines and the results were found to be satisfactory. The result of mean % recovery was found to be 99.42 + 0.36% for TDF which shows that the method was not affected by the presence of common excipients in tablet dosage form. The % RSD for both inter-day and intra-day precision was found to be less than 2.0%. The limit of detection and limit of quantification were found to be 0.47 μg/ml and 1.63 μg/ml respectively. The method was validated by determining its sensitivity, linearity, accuracy and precision which proves suitability of the developed method for the routine quality control analysis for the estimation of Tenofovir disoproxil fumarate (TDF) in bulk and tablet dosage form.