Author(s): Selvadurai Muralidharan*,Lim Boon Han, John Lau Yew Ming, Sailishni Kartigayam and Sokkalingam Arumugam Dhanaraj
The aim of this study was to develop and validate an isocratic reversed phase high-performance liquidchromatographic method for quantification of ketotifen fumarate(KF)in pharmaceutical solid dosage formulations.Simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the estimation of ketotifen fumaratein Tabletdosage form. A Thermo C18,250mmx 4.6mm id in Isocratic mode with mobile phase containing methanol: 10 mM ammonium acetate(30:70 %v/v pH: 3.5) was used. The flow rate was 1ml/min and effluents were monitored at 298nm. The retention time of ketotifen fumaratewas 5 min. The concentration curves were linear in the concentration range of 5to 150 ng/ml. The developed method was validated for specificity, precision, linearity, accuracy, ruggedness, robustness and solution stability. Recovery of ketotifen fumaratein formulations was found to be in the range of 97.36 % to 99.93 %. Proposedmethod was successfully applied for the quantitative determination of ketotifen fumaratein formulations.