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Spectrophotometric method development and validation for simultaneous analysis of Ketotifen fumarate and Cetirizine dihydrochloride in pharmaceutical dosage form

Ruchika Patel, Prachi Kabra, Ritu Kimbahune, Satya Vijay Singh, L.V.G.Nargund

In present research work, a simple Multicomponent Spectrophotometric method for simultaneous estimation of Ketotifen fumarate and Cetirizine dihydrochloride in pharmaceutical dosage was developed. The method used is inbuilt application of instrument (Shimadzu Pharm Spec 1700, UV spectrophotometer) to quantify Ketotifen fumarate and Cetirizine dihydrochloride in formulation. Considering the absorption of both analytes in the range of 200-360 nmin water, the wavelength intervals of 40 nmwas selected such as 360 nm, 320 nm, 280 nm, 240 nm and 200 nm for measurements. The serial dilutions of standard were scanned and absorptions were stored and sample concentration was determined by the instrument. The mean assay was found as about 100.3 %. The method has been validated in accordancewith ICH guidelines for accuracy and precision. Result of recovery study was observed in the range of 98.78% to 101.48% forKetotifen fumarate and 98.77%to 101.48%forCetirizine dihydrochloride. The % RSD for precision study was found as less than 1. The developed method is simple, accurate and economical so can be used for the routine analysis of Ketotifen fumarate and Cetirizine dihydrochloride from tablet dosage form.