Made available in DSpace on 2014-07-28T18:10:45Z (GMT). No. of bitstreams: 2 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) 84.pdf: 3245314 bytes, checksum: c5a4897524b601c32c4331343e8de94c (MD5) Previous issue date: 2008 / Made available in DSpace on 2014-12-22T16:56:34Z (GMT). No. of bitstreams: 2 84.pdf: 3245314 bytes, checksum: c5a4897524b601c32c4331343e8de94c (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2008 / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde / Um procedimento analítico é considerado apropriado para uma aplicação específica quando é capaz de gerar resultados confiáveis (precisos e exatos), que possibilitem a tomada de decisão com grau de confiança adequado. O presente trabalho tem como objetivo avaliar a confiabilidade dos resultados gerados a partir das verificações físicas e químicas do ensaio de dissolução de medicamentos feitos no INCQS no período de 1983 a 2008. Os resultados obtidos nas verificações químicas, dos comprimidos de referência contribuíram para a sustentação dos procedimentos analíticos empregados desde a implantação deste ensaio no contexto das análises no Departamento de Química do INCQS. A partir dos porcentuais dissolvidos das substâncias ativas (prednisona e ácido salicílico) presentes nos comprimidos de referência ao longo dos anos, construíram-se tabelas e gráficos, o que propiciou avaliar o desempenho do instrumental de dissolução. A avaliação das diversas fontes que poderiam contribuir para a incerteza do resultado de dissolução utilizando-se a ferramenta Diagrama de Causa e Efeito foi determinante para a visualização e identificação das principais contribuições na incerteza total do resultado final. / An analytical procedure is considered adequate for a specific application when it is able to produce reliable results (precise and accurate), that make it possible to reach a conclusion with a suitable degree of confidence. The purpose of this study is to assess the reliability of the results generated by the physical and chemical inspections of drug dissolution assays carried out at the INCQS from 1983 to 2008. The results obtained from such chemical inspections (of the reference tablets) contributed to support the analytical procedures applied since the implementation of this assay, in the context of the analyses in the INCQS Department of Chemistry. Tables and charts were produced based on the dissolved percentages of the active substances (prednisone and salicylic acid) observable in the reference tablets over the years, making it possible to evaluate the performance of the method of dissolution. The evaluation of the various sources that could contribute to the uncertainty of the dissolution result, using as a tool, the Cause and Effect Diagram, was crucial for the visualization and identification of the main contributions to the overall uncertainty of the final result. In order to perform this study, it was necessary make an evaluation of: the uncertainty of the chemical substance of reference (uncertainty of 0.5), the uncertainty of the declared concentration of the active substance, prednisone, in the reference tablet (5 % of 10 mg), and the influence of the instrumental system (with the 12 readings of absorbance used for the calculation of the concentration of the active substance released into each dish from the reference tablet). The realization of this study led to the conclusion that the main contributions to the uncertainty of the percentage of the active substance, prednisone, released from its matrix (the reference tablet), in the dissolution medium, were: the relative uncertainty of the CP2 standard reading (2.2 %), the relative uncertainty of the spectrophotometer (4.9 %), and the relative uncertainty of the sample reading (92.9 %), in relation to the relative Uncertainty of the % of dissolution. The latter is the main and major source of uncertainty, because in the dissolution assay what is assessed is the variability of the product.