DEVELOPMENT AND VALIDATION OF NEW HPT LC METHOD FOR SIMULTANEOUS ESTIMATION OF RUPATIDINE FUMARATE AND MONTELUKAST SODIUM IN TABLET DOSAGE FORM

A new simple high performance thin layer chromatographic method for simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and tablet dosage form was investigated. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of acetone:methanol:toluene (2:3:5, V/V/V). Densitometric evaluation of the separated zones was performed at 286 nm and the method was validated. The Rf values and drug content of rupatidine fumarate and montelukast sodium were 0.57±0.02, 0.68±0.02 and 98.3%, 97.67% respectively. The calibration curves of peak area versus concentration, were linear from 50-300 ng per band for both rupatidine fumarate and montelukast sodium and the regression coefficient (r2 ) was greater than 0.99. The method was validated for linearity, accuracy, robustness and application for assay as per ICH guidelines. The study showed that the developed method was simple and accurate and would be suitable for the simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and pharmaceutical formulations.