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SimultaneousRP-HPLCdetermination of bambuterolHCl and montelukast sodiumin pharmaceutical preparations

V.V.Vaidya, G.R.Singh, M.B.Kekare, M.P.Choukekar

A simple, fast and precise reversed phase high performance liquid chromatographic method is developed for the simultaneous determination of bambuterol HCl and montelukast sodiumusing mebeverine hcl as an internal standard. Chromatographic separation was performed on a waters symmetry C18 column (150mm4.6mm, 5m) as stationary phase with amobile phase comprising of 0.05% trifluoro acetic acid in water: 0.05% trifluoro acetic acid in acetonitrile (45:55 v/v), at a flow rate of 0.7mL min-1 and UV detection at 215nm. The Retention time of Bambuterol hcl, montelukast sodiumand Mebeverine HCl were 1.270 min, 4.322 and 1.604 min respectively. The proposed method was validated for linearity, accuracy, precision, LOD, LOQ. Linearity, accuracy and precisionwere found to be acceptable over the ranges of 250-750g mL-1 for both bambuterol HCl and montelukast sodium. It can be conveniently adopted for routine quality control analysis.