Development of Validated HPTLC Method for Simultaneous Estimation of Fexofenadine Hydrochloride and Montelukast Sodium in Tablet Dosage form

Abstract

A simple, precise, specific and accurate high performance thin layer chromatographic method has been developed for the simultaneous estimation of Fexofenadine hydrochloride (FEXO) and Montelukast sodium (MONT) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminium plates of silica gel G60 F254, (20 × 10 cm) with 250 μm thickness using hexane: ethyl acetate: propanol (2: 5: 3, v/v/v) as mobile phase. Densitometric measurement was carried out in the absorbance mode at 230 nm. The drugs were resolved satisfactorily with R values of 0.31 ± 0.01 and 0.57 ± 0.01 for FEXO and MONT, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.9996 and 0.9998 for FEXO and MONT, respectively in the concentration range of 1200–6000 ng spot−1 for FEXO and 100–500 ng spot−1 for MONT. The method was validated for precision, robustness, specificity and accuracy. The limit of detection and quantitation were 393 and 1193 ng spot−1, respectively for FEXO and 37 and 112 ng spot−1, respectively for MONT. The proposed method can be successfully used to determine the drug content of marketed formulation.