Determination of Montelukast Sodium in Raw Material and Solid Dosage Form Using Reverse Phase HPLC

Abstract

The purpose of the present study was to develop a new simple, accurate, precise and economic reverse phase HPLC method for the determination of montelukast sodium in bulk and pharmaceutical tablet dosage form. The separation of analyte was carried on lichorosovol octylsilyl (5 μm 250 mm × 4.6 mm) C₈ column and the mobile phase was fixed to acetonitrile and sodium acetate buffer (adjusted to pH 4 with acetic acid), in the proportion of 80:20 v/v, UV detection was carried out at 350 nm with a flow rate of 1 mL/min. The developed method showed that Beer's law was obeyed in range of 0.00008-0.2 mg/mL having correlation coefficient (R²) of 0.999. The per cent recovery was found from 100-103.28 % which indicate that the method is precise and reproducible. LOD and LOQ of drug were 0.00008 and 0.004 mg/mL, respectively. Precision, specificity, robustness studies showed good repeatability of the applied method. Percentage relative standard deviation values were found less than 2 % for proposed method. It was concluded that proposed method was versatile, low cost, accurate, selective, precise and rapid for the analysis of montelukast sodium.