Analytical Method Development and Validation for Simultaneous Estimation of Montelukast and Rupatadine by Using RP-HPLC Method Development on Bulk and Solid Dosage Forms

The aim of this study was to develop simple, advance, accurate and precise method for the quantification of Montelukast and Rupatadine in Pharmaceutical Dosage form and Bulk by using high Performance Liquid Chromatography (HPLC) technique.The chromatogram was run through a Kromosil C18 Column, 5 µm, 4.6 mm X 150 mm, with a mobile phase containing Buffer 0.01N Potassium dihydrogen phosphate: Acetonitrile taken in a ratio of 70:30 %v/v pumped through the column at a flow rate of 1.0 ml/min. The optimal wavelength chosen for this method was 232.0 nm, and Retention time of Montelukast and Rupatadine were found to be 2.361 min and 3.100 min. %RSD of the Montelukast and Rupatadine were and found to be 0.6% and 0.4% respectively. %Recovery was obtained as 100.22% and 99.00% for Montelukast and Rupatadine respectively. LOD, LOQ values obtained from regression equations of Montelukast and Rupatadine were 0.02, 0.06 and 0.02, 0.06 respectively. %Assay was obtained as 99.76% and 99.37% for Montelukast and Rupatadine respectively. Regression equation of Montelukast is y = 84727x + 8121.7, y = 59604x + 5241.2 of Rupatadine, the developed method was also applied to monitor the forced degradation studies on the drug for testing for its ability to resolve the drug from their degradation products. The specificity of the developed method was evaluated by applying acid, base, oxidation, thermal, photolytic and neutral stress conditions to the drug. It was concluded that the estimation of Montelukast and Rupatadine in bulk and its pharmaceutical dosage form was found to be successfully conducted by using the method.