Development and validation of HPTLC method for simultaneous estimation of montelukast sodium and fexofenadine hydrochloridein combined dosage form

摘要

A simple, precise, specific and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of Fexofenadine hydrochloride (FEXO) and Montelukast sodium (MONT) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel G60 F254, (20 × 10 cm) with 250 μm thickness using ethyl acetate: methanol: ammonia (30%) (7: 3: 0.5, 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 215 nm. The drugs were resolved satisfactorily with Rf values of 0.84 ± 0.01 and 0.24 ± 0.01 for MONT and FEXO, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with R2=0.9988 and 0.9995 for FEXO and MONT, respectively in the concentration range of 1800- 9000 ng/spot for FEXO and 150-750 ng ng/spot for MONT. The method was validated for accuracy, precision, specificity and robustness. The limit of detection and quantitation were 100.6079 and 304.8726 ng/spot, respectively for FEXO and 40.0191 and 121.8456 ng/spot, respectively for MONT. The proposed developed HPTLC method can be applied for identification and quantitative determination of FEXO and MONT in bulk drug and drug formulation.