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