Development and Validation of Analytical Method for The Simultaneous Estimation of Montelukast sodium and Desloratadine in Bulk and In Their Tablet Dosage Form

Abstract

A simple, accurate, precise and stability Indicating RP-HPLC method was developed and validated for simultaneous estimation of Montelukast sodium and Desloratadine in bulk and in their tablet dosage form. The RP-HPLC method has shown adequate separation for Montelukast sodium and Desloratadine from its degradation products. The separation was achieved on a Hypersil BDS C18 (250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of phosphate buffer : Methanol pH 3.5 adjusted with orthophospharic acid in the ratio of 60:40 v/v. The mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength of detection was kept at 246nm. The retention time for Montelukast A simple, accurate, precise and stability Indicating RP-HPLC method was developed and validated for simultaneous estimation of Montelukast sodium and Desloratadine in bulk and in their tablet dosage form. The RP-HPLC method has shown adequate separation for Montelukast sodium and Desloratadine from its degradation products. The separation was achieved on a Hypersil BDS C18 (250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of phosphate buffer : Methanol pH 3.5 adjusted with orthophospharic acid in the ratio of 60:40 v/v. The mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength of detection was kept at 246nm. The retention time for Montelukast