OPTIMIZATION AND VALIDATION OF HPLC METHOD FOR THE ANALYSIS OF KETOTIFEN FUMARATE IN A PHARMACEUTICAL FORMULATION

Abstract

A reversed phase high-performance liq. chromatog. (HPLC) method was developed and validated for detn. of ketotifen fumarate in a pharmaceutical formulation. The drug was chromatographed on reversed-phase C18 column, using mixts. of phosphate buffer/acetonitrile. The eluents were monitored at different wavelengths. The method was validated statistically for its linearity, accuracy, robustness and precision. Exptl. design was used during validation to evaluate method robustness and for the detn. of intermediate precision. Factors examd. for statistical approaches include; lab., day, analyst, instrument, percentage of org. modifier, wavelength and flow-rate. Due to its simplicity and accuracy, the method percentage may be used for routine quality control anal. [on SciFinder(R)]