Simultaneous RP-HPLC Method for the Estimation of the Emtricitabine, Tenofovir Disoproxil Fumerate and Efavirenz in Tablet Dosage Forms
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A simultaneous stability indicating RP-HPLC method is developed for the estimation of Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz in tablet dosage form. Chromatography was carried on an Inertsil ODS 3V column using gradient composition of 0.02M sodium dihydrogen orthophosphaste as mobile phase A and mixture of Methanol and water in ratio of 85:15 as mobile phase B at a flow rate of 1.5 ml/min with detection at 265 nm. The retention times of the Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz was about 5.875, 8.800 and 12.020 mins respectively. The detector response is linear from 8120μg/ml, 12–180μg/ml, 20–360μg/ml of test concentration for Emtricitabine, Tenofovir and Efavirenz respectively. The respective linear regression equation being Y=10175x-76883 for Emtricitabine, Y=6280.8x+219800 for Tenofovir disoproxil fumerate and Y=1883.5x+323060 for Efavirenz. The limit of detection and Limit of quantification was 0.06, 0.07 and 0.08 μg/ml and 0.14, 0.12 and 0.15μg/ml for Emtricitabine, Tenofovir and Efavirenz respectively. The percentage assay of Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz was 99.31, 99.77 and 100.20% respectively and percentage recovery for average of three different concentrations was 100.87%, 100.04% and 99.52% respectively. The method was validated by determining its sensitivity, Linearity, accuracy and precision. The proposed method is simple, fast, sensitive, Linear, accurate, rugged and precise and hence can be applied for routine quality control of Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz in bulk and in tablet dosage form.
Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz, Shimadzu HPLC with PDA detector, Inertsil ODS 3V and Tablets.