Analytical Method Development and Validation of Montelukast Sodium and Bambuterol Hydrochloride in Combined Dosage Form by RP-HPLC

This research paper describes simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method for the simultaneous determination of Montelukast sodium and Bambuterol hydrochloride in combined dosage form. The sample was analyzed by reverse phase C18 column (Phenomenex C18, 5μ, 250mm x 4.6mm) as stationary phase; methanol: acetonitrile : 1% trichloroacetic acid in the ratio of 80:10:10 v/v/v as a mobile phase at a flow rate of 1.0ml/min. Quantification was achieved with ultraviolet detection at 220 nm. The retention time for Montelukast sodium and Bambuterol hydrochloride was found to be 3.17 and 2.35 min, respectively. The linearity for both the drugs was in the range of 0.5-10 μg/ml with mean accuracies 100.06 ± 0.49 and 99.95 ± 0.63 for Montelukast sodium and Bambuterol hydrochloride, respectively. The method was successively applied to pharmaceutical formulation because no chromatographic interferences from the tablet excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.