A reversed phase high-performance liquid chromatographic (HPLC) method was developed and validated for determination of ketotifen fumarate in a pharmaceutical formulation? The drug was chromatographed on reversed-phase C18 column, using mixtures of phosphate buffer/acetonitrile. The eluents were monitored at different wavelengths. The method was validated statistically for its linearity, accuracy, robustness and precision. Experimental design was used during validation to evaluate method robustness and for the determination of intermediate precision. Factors examined for statistical approaches include; laboratory, day, analyst, instrument, percentage of organic modifier, wavelength and flow-rate. Due to its simplicity and accuracy, the method percentage may be used for routine quality control analysis.