Abstract
A simple, precise, specific and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of Montelukast (MONT) and Doxofylline (DOXO) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel G60 F254, (10 × 10 cm) with 250 μm thickness using Toluene : ethyl acetate : methanol : Glacial aceticacid (6 : 3.4 : 3 : 0.1, v/v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 280 nm. The drugs were resolved satisfactorily with Rf values of 0.82 ± 0.01 and 0.72 ± 0.01 for MONT and DOXO, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with R2=0.9998 and 0.9986 for MONT and DOXO, respectively in the concentration range of 200-1000 ng/spot for MONT and 8000-40000 ng/spot for DOXO. The method was validated for accuracy, precision, specificity and robustness. The limit of detection and quantitation were 100.54 and 304.66 ng/spot, respectively for MONT and 1333.79 and 4041.78 ng/spot, respectively for DOXO. The proposed developed HPTLC method can be applied for identification and quantitative determination of DOXO and MONT in bulk drug and drug formulation.
