Thin-layer chromatographic‒densitometric method of analysis for the estimation of montelukast and bilastine in combination

Abstract

A precise, accurate and sensitive high-performance thin-layer chromatographic method has been developed and validated for the simultaneous determination of montelukast and bilastine in a tablet dosage form which is used in the treatment of allergic rhinitis. The proposed method used aluminum plates pre-coated with silica gel 60F254 as the stationary phase and acetonitrile–ethyl acetate–ammonia (4:6:0.1, V/V) as the mobile phase for separation purpose. Densitometric detection was carried out at 282 nm in ultraviolet. Compact spots of montelukast and bilastine were obtained at RF 0.53 and 0.27, respectively. Linear responses were shown by the detector over the range of 100‒500 ng/band for montelukast and 200‒1000 ng/band for bilastine. The proposed method was validated as per the International Council for Harmonisation guidelines. The method was applied for the estimation of both drugs in tablet formulation and their synthetic mixture.