Abstract

Development and Validation of an Alternate Stability-indicating UV Spectrophotometric Analytical Method for Aspirin in Tablets

Author(s): M. Dolores, E. A. Morales-Hipolito, J. A. Garduno-Rosas, A. Villasenor and R. Lopez-Arellano*
Pharmaceutical Development Testing Laboratory, Multidisciplinary Research Unit (UIM), Faculty of Higher Cuautitlán, National Autonomous University of Mexico, Mexico

Correspondence Address:
Pharmaceutical Development Testing Laboratory, Multidisciplinary Research Unit (UIM), Faculty of Higher Cuautitlán, National Autonomous University of Mexico, Mexico E-mail: [email protected]


Aspirin is a worldwide drug that has been used for more than a century. Numerous analytical stability indicating methods have been reported over the years. Accomplishing the repertoire, a new stability indicating method was developed for the accurate quantitation of aspirin in tablets using the partial least squares calibration algorithm. The method is specific for the determination of aspirin and its main degradation product; salicylic acid in tablets using ultraviolet spectrophotometry. The calibration matrix needs only 13 binary solutions and the method showed good linearity from 30-70 µg/ml for aspirin and 0-40 µg/ml for salicylic acid. Moreover, a full validation according to the International Council of Harmonization guidelines was carried out covering precision, recovery, sensitivity, sample stability and tolerance. The method was applied to developed and commercial aspirin tablets. The proposed method represents a reliable choice to be used as a routine method for quality control of newly manufactured products



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