VALIDATED HPTLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF EMTRICITABINE AND TENOFOVIR IN DRUG FORMULATIONAbstract
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 Rf 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.
P.G. Sunitha and K. Ilango *
Department of Pharmaceutical Chemistry , SRM College of Pharmacy, SRM University, Kattankulathur, Tamil Nadu, India
24 October, 2014
15 December, 2014
11 February, 2015
01 June, 2015