Journal of the Chilean Chemical Society
versión ISSN 0717-9707
CHANDRA, P; RATHORE, A. S; SATHIYANARAYANAN, L y MAHADIK, K. R. APPLICATION OF HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE IN PHARMACEUTICAL DOSAGE FORM. J. Chil. Chem. Soc. [online]. 2011, vol.56, n.2, pp. 702-705. ISSN 0717-9707. doi: 10.4067/S0717-97072011000200017.
A simple, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of lamivudine (LAM) and tenofovir disoproxil fumarate (TDF) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel 60 F254,(20 x 10 cm) with 250 µm thickness using chloroform: methanol: toluene (8: 2: 2, v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 265 nm. The drugs were satisfactorily resolved with Rf values of 0.27± 0.01 and 0.51± 0.01 for LAM and TDF, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.9999 and 0.9996 for LAM and TDF, respectively in the concentration range of 60-210 ng spot1 for each drug. The method was validated for precision, robustness, specificity and accuracy The limit of detection and quantitation were 20 and 40 ng spot1, respectively for LAM and 30 and 60 ng spot1, respectively for TDF. The proposed developed HPTLC method can be applied for identification and quantitative determination of LAM and TDF in bulk drug and pharmaceutical dosage form.
Palabras clave : lamivudine; tenofovir disoproxil fumarate; HPTLC; validation.