Desenvolvimento de um teste de dissolução para comprimidos de nimesulida em meio que assegure condições sink
The aim of this work was to develope a dissolution test for nimesulide immediate release tablets in a medium that assure sink conditions. A solubility study was elaborate to assist in the selection of a dissolution medium. Media containing surfactants and with modification of the pH were evaluated....
Guardado en:
| Autores principales: | , , |
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| Formato: | Articulo |
| Lenguaje: | Portugués |
| Publicado: |
2009
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| Materias: | |
| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/7818 http://www.latamjpharm.org/trabajos/28/5/LAJOP_28_5_1_3_5K6E9AQ727.pdf |
| Aporte de: |
| Sumario: | The aim of this work was to develope a dissolution test for nimesulide immediate release tablets in a medium that assure sink conditions. A solubility study was elaborate to assist in the selection of a dissolution medium. Media containing surfactants and with modification of the pH were evaluated. Medium pH 7.40 containing Tween 80 presented the larger nimesulide solubility. The best dissolution results were obtained in 900 mL of medium phosphate buffer (0.05 M, pH 7.40) + 1.0% m/v Tween 80 using paddle apparatus at 75 rpm. Dissolution study was validated performing the drug quantification by HPLC and spectrophotometry. The validation presented satisfactory parameters (linearity, selectivity, precision, accuracy and sensibility) for both methods. This way, it was possible to establish conditions and specifications for dissolution test of nimesulide tablets as a quality control tool, as well to standardize appropriate analytical methods for drug quantification in dissolution medium. |
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