Optimization of a new dissolution test for oxcarbazepine capsules using mixed-level factorial design

In this work, a dissolution test for oxcarbazepine capsules was developed and validated. For the screening study, a mixed-level factorial design containing factors at three and two levels (3² × 2) was used in order to select the stirring speed, the dissolution medium and the dissolution apparatus. T...

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Bibliographic Details
Published in:Journal of the Brazilian Chemical Society 2011-07, Vol.22 (7), p.1263-1270
Main Authors: Polonini, Hudson C, Oliveira, Marcone A. L. de, Ferreira, Anderson O, Raposo, Nádia R. B, Grossi, Lívia N, Brandão, Marcos A. F
Format: Article
Language:English
Subjects:
CHEMISTRY, MULTIDISCIPLINARY
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Summary:In this work, a dissolution test for oxcarbazepine capsules was developed and validated. For the screening study, a mixed-level factorial design containing factors at three and two levels (3² × 2) was used in order to select the stirring speed, the dissolution medium and the dissolution apparatus. This strategy is needful for reducing the time of method development and to provide less ambiguous data. The best in vitro percentage dissolution was obtained using apparatus paddle at 80 rpm and sodium lauryl sulfate 1% m/v aqueous solution as the dissolution medium. The quantification of the mass dissolved was obtained by UV-Vis spectrophotometric analysis at 304 nm. The validation results demonstrate that the method was precise and linear over the range of 83-249 µg mL-1 of oxcarbazepine. Thus, the method is useful and adequate for oxcarbazepine capsules dissolution test, once there is no official monograph regarding it.
ISSN:0103-5053
1678-4790
DOI:10.1590/S0103-50532011000700011