UV-SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF TENOFOVIR DISOPROXIL FUMERATE AND EMTRICITABINE AND ITS COMPARISON WITH RP-HPLC AND TLC DENSITOMETRY DETERMINATION

摘要

This paper describes validated derivative spectrophotometry (D2) method for simultaneous estimation of tenofovir disoproxil fumerate (TF) and emtricitabine (EM) in formulation. Second derivative spectrophotometry method, applying the peak zero method, was developed for the determination of tenofovir disoproxil fumerate and emtricitabine in their combined tablet formulations without prior separation. Quantitative determination of the drugs was performed at 342.8 and 298.3 nm for tenofovir disoproxil fumerate and emtricitabine, respectively. Second RP-HPLC method for simultaneous analysis of tenofovir disoproxil fumerate and emtricitabine has been developed and validated. The quantification was carried out using a thermo-hypersil ODS-C18 (250 mm × 4.6 mm, 5.0 μ) column and mobile phase comprised of acetonitrile: 0.05M potassium dihydrogen phosphate with triethylamine (65: 35 v/v). Total run time was less than 8 min; retention time for tenofovir disoproxil fumerate and emtricitabine was 6.841 and 7.415 min, respectively. TLC-densitometry method has been developed and validated for the determination of tenofovir disoproxil fumerate and emtricitabine in dosage form. The stationary phase used was pre-coated silica gel 60F_(254). The mobile phase used was a mixture of chloroformrcarbon tetrachloride:acetone (6:4:2 v/v/v). The detection of spot was carried out at 246.4 nm. The method was validated in terms of linearity, accuracy, precision and specificity.