Method Development and Validation for Estimation of Tinofovir Disoproxil Fumarate in Pharmaceutical Preparation by UV-Spectroscopy and HPLC with Force Degradation Study

Tinofovir Disoproxil Fumarate (TDF) is an acyclic nucleotide diester analog of adenosine monophosphate from the antiviral category utilized in the AIDS and hepatitis B treatment. In the present study, two analytical methods, i.e. UV and HPLC were developed for the TDF’s estimation in pharmaceutical preparation. In the UV method, the mobile phase used was Methanol and water in 60:40 ratio for estimation of the drug at 260 nm and an assay of the (TDF) obtained was 99.53%. The method’s validation was carried out as per ICH Q2 R1 guidelines in which linearity was detected from 10-50 µg/ml range with a regression value of 0.999 Percent RSD value of accuracy, precision and robustness were below 2. In the HPLC method estimation of (TDF) was evaluated on Cosmosil C-18 (250mm×4.6ID, Particle size: 5 µ) column utilizing Methanol: Water (60:40), 0.9 ml/min of flow rate, detection wavelength was 260 nm and the time of retention observed was around 4.63 minutes with the assay value 99.07%. HPLC method was also validated according to ICH guidelines, where linearity was detected in the 10-50 μg/ml of range with the regression coefficient value 0.999. The % RSD of precision, accuracy, and robustness was below 2%. The study of forced degradation was also performed by the HPLC method utilizing methanol: water (60:40) at 260nm. From this study, it can be concluded that the developed methods for estimation of (TDF) drug in pharmaceutical preparation are simple, accurate, precise, and can be utilized in the routine analysis for quantification of the drug in a dosage form.