Stability Indicating RP-HPLC Method for the Estimation of Emtricitabine and Tenofovir Disoproxil Fumerate in Tablet Dosage Form

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 μg/mLand 0.306, 0.575 μg/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.

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