Froehlich, Pedro Eduardo

Junqueira, César Alexandre

English

Lume 5.8

142 CONTROLE DE QUALIDADE DE INSUMOS FARMACÊUTICOS E MEDICAMENTOS Quality contrai of pharmaceutical raw materiais and medicines QUANTITATIVE DETERMINATION OF DRUGS BY DIRECT ANO INDIRECT METHODS: AN EXPERIMENTAL STUDY Junqueira, C.A. 1:; Frõehlich; P.E. 1 1Laboratório de Química Farmacêutica, Faculdade de Farmácia, UFRGS *Mestrando -Início: 2010/4 lntroduction: Purity is one of the main attributes of quality of bulk drug materiais, since the identification and quantitative determination of impurities and degradation products can help to avoid or at least control/minimize the risk of their contribution to the side effect profile of drug materiais 1. The role of assay methods, either specific or non-specific, in characterizing the quality of bulk drug materiais, has been questioned1·2 . On the other hand, the mass balance approach (100- impurities%) has been considered as a more precise and accurate method 3. Additionally, as a consequence of development in the methods for identification and quantitative determination the focal point of characterizing the quality of drug materiais has shifted from assay methods to impurity tests 1·2 . Objective: To compare compendiai assay methods with a mass balance approach in the determination of the active ingredient content and characterization of the quality of bulk drug materiais. Materiais and Methods: The specific and non-specific compendiai assays in the Farmacopéia Brasileira4 and United States Pharmacopeia5 will be critically evaluated and compared with a different approach of mass balance. Reference chemical substances from the Farmacopéia Brasileira will be used for this purpose. Only bulk drug materiais will be dealt with, excluding from this study pharmaceutical formulations. The techniques to be employed in the indirect method include loss on drying, residue on ignition, water determination, and determination of organic impurities with HPLC-UV and GC-MS. The possibilities to calculate the active ingredient content from the results of assay and impurity tests will be investigated and co~red. The results will be statistically treated with ANOVA. Finally, the roles of both approaches iry characterizing the quality of bulk drug materiais will be discussed. References: 1. S. GOROG. J. Pharm. Biomed. Anal. 48, 2008. 2. S. GQROG. J. Pharm. Biomed. Anal. 36, 2005. 3. J. D. HOFER; B. A. OLSEN; E. C. RICKARD. J. Pharm. Biomed. Anal. 44, 2007. 4. F. BRAS. IV. Farmacopéia Brasileira, 4.ed. Atheneu: São Paulo, 1988. 5. USP. The United States Pharmacopeia. 30. Ed. Rockville: The United States Convention, 2007. Acknowldgements: Financiai support from CNPq/Brazil. 

Quantitative determination of drugs by direct and indirect methods : an experimental study

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Quantitative determination of drugs by direct and indirect methods : an experimental study

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Lume 5.8