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Simultaneous HPTLC determination of bambuterol HCl in pharmaceutical preparations

P.S.Barde, Shikha M.N.Roy, A.Y.Desai, V.V.Vaidya, K.V.Mangaokar, K.V.Mangaokar

A simple, fast, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of Bambuterol HCl usingMebeverine HCl as an internal standard. Chromatographic separation of these two drugs was performed using Silica gel 60F 254 as stationary phase with a mobile phase comprising of Toluene : Ethyl acetate:Methanol and Glacial acetic acid (70:20:10:2 v/v). Under these conditions the Rf for Bambuterol peak was 0.10. Quantitation was achieved by densitometric scanning at 254nm. The Rf values for Bambuterol HCl and Mebeverine HClwere 0.10 and 0.30 respectively. The proposedmethodwas validated for linearity, accuracy, precision. The response to BambuterolHCl was a linear function of concentration over the range 125-1000 µg mL-1 i.e. 25% to 200% of the working assay concentration. The method permits reliable quantification of Bambuterol HCl and good resolution and separation ofBambuterolHCl frominternal standard ofMebeverine HCl. It can be conveniently adopted for routine quality control analysis.