A novel combination of Acebrophylline and Montelukast Sodium is used in the treatment of chronic obstructive pulmonary disease (COPD) and bronchial asthma. A novel Reversed-phase high-performance liquid chromatographic method for the simultaneous determination of Acebrophylline and Montelukast sodium was developed and validated. A reversed phase high-performance liquid chromatographic analysis was performed on Unisphere C18 column (250 mm X 4.6 mm i.d., 5 µm particle size) at 40°C; the mobile phase, consisting of a mixture of Sodium acetate (200 mM, pH adjusted to 6 with glacial acetic acid): Methanol: Acetonitrile (20:30:50 v/v/v) was delivered at a flow rate of 1.0 mL/min and detector wavelength at 272 nm. The retention time of Theophylline-7-acetate and Ambroxol was found to be 2.22 and 4.52 min respectively as an individual component of Acebrophylline and 5.22 min for Montelukast sodium. Linearity ranges were 100-600 and 5-30 µg/ ml with limit of detection values of 0.52 and 0.05µg/ml for Acebrophylline and Montelukast sodium respectively In First order derivative spectroscopy method, absorbance of Acebrophylline was measured at 282 nm (Zero Crossing Point of Montelukast sodium) and absorbance of Montelukast sodium was measured at 368 nm (Zero Crossing Point of Acebrophylline). The drugs obeyed the Beer’s law in the concentration range of 20-140 µg/ml for Acebrophylline and 1-7 µg/ml for Montelukast sodium. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. Correlation coefficients (r2) of the regression equations were greater than 0.999 in all cases. According to the validation results, the proposed methods were found to be specific, accurate, and precise and could be applied to the simultaneous quantitative analysis of Acebrophylline and Montelukast sodium in pharmaceutical formulation.
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