ABSTRACT:
A simple, accurate and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous quantitative estimation of Emtricitabine (EMT) and Tenofovir disoproxil fumerate (TDF) in tablet dosage form. Quantitation was carried on an ACE (150 mm x 4.6mm, 5µ) column using gradient composition of 0.01 M citric acid monohydrate buffer pH 4.5 as mobile phase A and methanol as mobile phase B at a flow rate of 1.0 mL/min with detection at 260 nm. Determination of the different validation parameters such as precision, linearity, accuracy, specificity, robustness, limit of detection, limit of quantification and filter validation was done. The system suitability parameters such as retention time, theoretical plates and tailing factor were found to be 3.181min, 13438, 0.14 and 6.090min, 48847, 1.05 respectively for EMT and TDF. The detector response is linear from 16 µg/mL to 64 µg/mL for EMT and 24 µg/mL to 96 µg/mL TDF. The limit of detection and limit of quantification was 0.101, 0.189 microgram/mLand 0.306, 0.575 microgram/mL for EMT and TDF respectively. The percentage recovery for average of three different concentrations (50, 100 and 150%) was 101.1, 100.6, 99.8 and 99.7, 99.4, 99.6% for EMT and TDF respectively.The high percentage of recovery and low % RSD confirms the suitability of the method for the simultaneous estimation of EMT and TDF in tablet dosage form.The method could effectively separate the drugs from their degradation products, it can be regarded as stability indicating method.