SIMULTANEOUS EQUATION METHOD AND Q-ABSORPTION RATIO METHODS DEVELOPMENT AND VALIDATION OF KETOTIFEN FUMARATE AND THEOPHYLLINE IN BULK AND DOSAGE FORM
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2014, Vol 5, Issue 5
Abstract
A simple, accurate and precise UV- Spectroscopy method for the simultaneous estimation of Ketotifen fumarate and theophylline in Bulk and Dosage form has been developed and validated. Absorbance of ketotifen fumarate and theophylline measured at 296 nm and 271 nm for simultaneous equation method and 281 nm and 271 nm for the Q-absorption ratio method respectively. The drug response with respect to absorbance was linear over the concentration range 2-16 μg/ml (n = 5) for ketotifen fumarate and 4-32 μg/ml for theophylline. The percentage recovery of ketotifen fumarate and theophylline was found to be 99.65-100.95 % and 99.68-100.47 % respectively for simultaneous equation method and 99.07-100.55 % and 99.98-100.65 % respectively for Q-absorption ratio method. The %RSD values for intra-day precision study and inter-day study were ≤ 2.0 %, confirming that the method was sufficiently precise. The system stability test parameters were also performed and were found to be within acceptable criteria. The method can be successfully employed for the simultaneous determination of Ketotifen fumarate and Theophylline in pharmaceutical formulation.
Authors and Affiliations
Narendra Chaudhari
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