VALIDATED HPTLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF EMTRICITABINE AND TENOFOVIR IN DRUG FORMULATION

A simple, precise, specific and accurate high-performance thin-layer chromatographic method has been developed for the simultaneous determination of Emtricitabine (EMB) and Tenofovir (TEN) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel 60 F₂₅₄, (20×10 cm) with 250 μm thickness using toluene: ethylacetate: methanol in the ratio (2:8:1 v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 272 nm. The drugs were resolved satisfactorily with R_f values of 0.44 and 0.68 for EMB and TEN, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9999 and 0.9995 for EMB and TEN, respectively, in the concentration range of 40–400ng spot⁻¹ for EMB and 200–700ng spot⁻¹ for TEN. The method was validated for precision, robustness, specificity and accuracy. The limits of detection and quantitation were 20 and 40ng spot⁻¹, respectively, for EMB and 100 and 200ng spot⁻¹, respectively, for TEN. The proposed HPTLC method can be applied for identification and quantitative determination of EMB and TEN in bulk drug and drug formulation.