METHOD DEVELOPMENT AND VALIDATION OF MONTELUKAST AND RUPATADINE IN TABLET DOSAGE FORMS BY RP-HPLC

Abstract

RP-HPLC method was developed for the simultaneous estimation of Montelukast and Rupatadine in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a Sunfire C18 column (250 × 4.6 mm, 5 μm) with a mobile phase consisting of Na₂HPO₄ buffer and acetonitrile in the ratio 60:40 % v/v, pumped at a flow rate of 1.0 mL/min. The detection wavelength was optimized at 235.0 nm and the column temperature was maintained at 30°C. The retention times of Montelukast and Rupatadine were found to be 2.280 min and 2.976 min, respectively. %RSD values of 0.5% for Montelukast and 0.4% for Rupatadine confirmed the precision of the method. Accuracy results demonstrated excellent recovery, with 99.64% for Montelukast and 99.54% for Rupatadine. LOD and LOQ for Montelukast were 0.03 μg/mL and 0.10 μg/mL, while for Rupatadine they were 0.01 μg/mL and 0.04 μg/mL, respectively, indicating the sensitivity of the method. The %Assay was obtained as 99.28% for Montelukast and 99.37% for Rupatadine. The regression equations were y = 64680x + 6030 for Montelukast and y = 66027x + 547.57 for Rupatadine, showing excellent linearity. Overall, the proposed RP-HPLC method was validated successfully and can be reliably applied for routine quality control analysis of Montelukast and Rupatadine in combined dosage forms.