RP- HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUMAND DESLORATIDINE FROM BULK AND TABLETS FORMULATION

Abstract

A simple, rapid, accurate, precise and validated High performance Liquid Chromatographic method for the simultaneous estimation of Desloratidine(DES) and Montelukast sodium(MON) in bulk and Multicomponant formulation. The Reversed-phase liquid chromatographic analysis was performed on a Hypersil C18 column (250mm, 4.6mm i.d., 5 μ m particle size) column with mobile phase Acetonitrile: 0.05M Potassium Dihydrogen ortho-phosphates with 1.5ml Triethylamine of pH 3 (65: 35 v/v) and column temperature at 40°C. The flow rate of the mobile phase was adjusted to 1.3 mL/min and the injection volume was 10 μ l. Detection was performed at 210 nm. The retention time for DES and MON were 2.12 min and 12.76 min respectively. The method was validated and shown to be linear for DES and MON in 10-60 μ g/mL (r²=0.998) and 20-120 μ g/mL (r²=0.998) respectively. The relative standard deviation of DES and MON for intra-day was 0.2746 and 0.7637 respectively, inter-day was found to be, 0.7836 and 0.9317 respectively. The developed RP- HPLC method is suitable for estimation of Montelukast sodium and Desloratidine in tablet formulation. Hence this method can be used in quality control for routine analysis of the finish drug product.