Abstract
A simple, efficient and reproducible Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for the estimation of Tenofovir Disoproxil Fumarate in Pharmaceutical formulation has been validated. The Separation was carried out on C-18 column 4.6 mm x 250 cm x 5 µm column at ambient temperature using Buffer: Acetonitrile in the ratio of 60: 40 as a mobile phase. The flow rate was 1 ml/min and effluent was detected at 260nm. The retention times was found to be 3 mts. The percentage recovery was within the range between 99.23% to 101.44 %. The method was linear in the range of 50%-150% for Tenofovir Disoproxil Fumarate where r2 = 0.999. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. The method was validated according to ICH guidelines and the acceptance criteria for specificity, linearity, accuracy, precision, ruggedness and robustness were met in all cases in detecting Tenofovir Disoproxil Fumarate. Hence the method could be successfully applied for routine analysis of Tenofovir Disoproxil Fumarate in the solid dosage form.
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