Abstract
The aim of this work was the development and validation of a dissolution methodology for desloratadine-coated tablets by spectrophotometry on ultraviolet (UV). 0.1 M hydrochloric acid (HCl), pH 4.5-citrate buffer and pH 6.8 phosphate buffer were tested as dissolution medium. In addition, influences of apparatus, and rotation speed were evaluated. After an UV scan spectrum from 500 to 200 nm, to determine the maximum wavelength absorbance, samples were analyzed by UV visible spectrophotometric method. The parameters selected were 0.1 M HCl as dissolution medium, using paddles as apparatus at 50 rpm, with analysis at wavelength of 280 nm. The method was validated as per ICH guidelines, and the results showed that the dissolution methodology for desloratadine-coated tablets with 0.1 M HCl as dissolution medium, using paddles as apparatus at 50 rpm, with analysis at wavelength of 280 nm, with sampling points at 5, 10, 15 and 30 minutes is specific, linear, precise and accurate and could be applied for quality control of desloratadine tablets, since there is no official monograph.
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