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Master's Dissertation
DOI
https://doi.org/10.11606/D.9.2019.tde-18122019-104005
Document
Author
Full name
Regina Celli Espires Carrion
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 1997
Supervisor
Committee
Magalhaes, Joao Fernandes (President)
Consiglieri, Vladi Olga
Gremião, Maria Palmira Daflon
Title in Portuguese
Aspectos da validação de métodos para doseamento do metronidazol em medicamentos
Keywords in Portuguese
Análise de medicamentos
Antiparasitarios (Farmacologia)
Controle de qualidade
Espectrofotometria
Medicamento
Validação
Abstract in Portuguese
Considerando a ampla e diversificada aplicação terapêutica do metronidazol aliada ao grande número de medicamentos e a extensa metodologia analítica descrita, o objetivo principal deste trabalho foi avaliar alguns métodos analíticos baseados nos princípios da validação e que pudessem ser usados por diferentes laboratórios de controle de qualidade. Foram estudados métodos espectrofotométricos no UV e no visível com hidrólise alcalina e redução do nitro grupo seguidas da reação de Bratton-Marshall, e com nitroprussiato de sódio e cloreto de hidroxilamônia visando a determinação de metronidazol e benzoilmetronidazol presentes em comprimidos e suspensões, respectivamente. Os parâmetros analíticos dos métodos foram avaliados e estabelecidas as condições experimentais adequadas, os mesmos foram aplicados às amostras de medicamentos. Para cada metodologia foram estudados a exatidão e precisão com as devidas considerações estatísticas. A linearidade foi avaliada em vários níveis de concentração e observada graficamente. O método espectrofotométrico no UV demonstrou ser adequado para análise de comprimidos e suspensões, enquanto o método espectrofotométrico com hidrólise alcalina e reação de Bratton-Marshall foi eficiente para comprimidos. O método titulométrico com ácido perclórico não demonstrou resultados satisfatórios para amostras comerciais de comprimidos. Os demais métodos estudados apresentaram valores que não satisfazem os critérios de aceitação.
Title in English
Aspectos da validação de métodos para doseamento do metronidazol em medicamentos
Keywords in English
Análise de medicamentos
Antiparasitarios (Farmacologia)
Controle de qualidade
Espectrofotometria
Medicamento
Validação
Abstract in English
Considering the ample and diversified therapeutic application of metronidazole allied at the great number of pharmaceutical preparations and the extensive analytic methodology described, the main target of this work was to evaluate some analytic methods taking in consideration the validation principles which could be used by difference laboratories of quality control. It was been studied spectrophotometric methods on UV and on visible with alkaline hydrolysis and reduction of nitro group followed by the Bratton-Marshall reaction, and with sodium nitroprusside and hydroxyl ammonium chloride in order to determinate of metronidazole and benzoyl metronidazole which are presents in tablets and suspension, respectively. The analytic parameters of the methods were been evaluated and the adequate experimental conditions were established, and the same were been applied to the pharmaceutical dosage forms. To each methodology were been studied the accuracy and precision with the due statistic considerations. The linearity was evaluated in several levels of concentration and graphically observed. The spectrophotometric method on UV showed be adequate for the analysis of tablets and suspension, while the spectrophotometric method with alkaline hydrolysis and Bratton-Marshall reaction was efficient for tablets. The non-aqueous titration with perchloric acid did not demonstrate satisfactory results for commercial samples of tablets. The other methods studied showed values, which does not satisfy the normal criterion of acceptance.
 
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Publishing Date
2019-12-18
 
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