The developed and validation for the estimation of Ketotifen fumarate by using UV spectrophotometric method was a simple, accurate, precise and more sensitive. In comparison to previous literature survey, our method was shown to be more sensitive. The standard stock solutions were prepared using analytical grade methanol as per procedure and were scan at maximum absorbance 298nm. The concentration range of 10-100 ng/ml was found to be linear. The coefficient in the (r2) was 0.9997. The regression equation was found to be y = 0.0278 X + 0.0184. According to the ICH guidelines, the developed method was validated and found to be accurate and precise. The validation parameters are the linearity, accuracy, precision, limit of deduction, limit of quantitation, robustness and ruggedness. The developed and the validated method can be successfully applied to the estimation of Ketotifen fumarate in bulk drugs and pharmaceutical dosage form for the routine analysis and monitoring of the quality of marketed drugs.
