DEVELOPMENT AND SIMULTANEOUS VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ASSAY OF MONTELUKAST AND RUPATADINE IN SOLID DOSAGE FORM

Abstract

This paper emphasizes on a new simple, accurate, rapid and precise Isocratic Reverse Phase HPLC method for Simultaneous Estimation and Validation of Montelukast sodium and Rupatadine fumarate in Tablet formulation.The Method was performed on Shimadzu-10AT HPLC system using YMC Pack pro-C4 butyl column-3u particle size(150x4.6mm id) and flow rate of 1ml/min with a load of 10ul. The mobile phase consists of organic phase as Acetonitrile and aqueous phase i.e buffer as Ammonium acetate adjusted to pH-3+0.2 with Acetic acid in the ratio of 80:20. Tailing modifier 1-Octane sulphonic acid was used in the experiment. The detection was carried out at 252nm. Retention time for Montelukast and Rupatadine were 3.4min and 4.1min respectively. Linearity was calculated over the range of 1-100ug/ml for Montelukast and Rupatadine respectively. The % regression for both drugs found to be at 0.999. Validation parameters like accuracy, precision, linearity, robustness, ruggedness were done according to ICH guidelines.