Analytical RP-HPLC Method Development and Its Validation for Estimation of Tenofovir Disoproxil Fumarate in Bulk and Pharmaceutical Formulation

A very few analytical methods appeared in the literature for the determination of Tenofovir disoproxil fumarate includes HPLC, HPTLC and UV- Visible spectrophotometric methods. In view of the above fact, some simple analytical methods were planned to develop with sensitivity, accuracy, precision and economical. In the present investigation HPLC method for the quantitative estimation of Tenofovir disoproxil fumarate in bulk drug and per ICH guidelines pharmaceutical formulations has been developed. HPLC methods were validated as and results of linearity, precision, accuracy, Specificity, System suitability and robustness pass the limit. The HPLC method is more sensitive, accurate and precise compared to the previously reported method. There was no any interference of excipients in the recovery study. The low value of %RSD, molar extinction coefficient (L mol-1 cm-1) suggested that the developed methods are sensitive.