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Master's Dissertation
DOI
https://doi.org/10.11606/D.9.2008.tde-03022009-180929
Document
Author
Full name
Fabio Pereira Gomes
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2008
Supervisor
Committee
Santoro, Maria Inês Rocha Miritello (President)
Mercuri, Lucildes Pita
Orsine, Eliane Maria de Almeida
Title in Portuguese
Validação de métodos para análise de estatinas em medicamentos
Keywords in Portuguese
Estatinas
Medicamento
Métodos analíticos
Validação
Abstract in Portuguese
As estatinas são substâncias que inibem a síntese de colesterol. Por não existir métodos analíticos simples e de baixo custo para determinação quantitativa de pravastatina sódica, fluvastatina sódica, atorvastatina cálcica e rosuvastatina cálcica, o objetivo desta pesquisa foi desenvolver, validar e comparar os métodos por cromatografia líquida de alta eficiência e espectrofotometria direta e derivada no ultravioleta para a determinação quantitativa de estatinas em comprimidos. Os métodos cromatográficos foram realizados em coluna LiChrospher® RP-18 com fase móvel composta de metanol-água e pH ajustado a 3,0 com ácido fosfórico. Os métodos espectrofotométricos foram validados utilizando NaOH 0,1 M como solvente. A análise estatística com os testes t e F, não mostraram diferença significativa entre os métodos propostos ao nível de confiança de 95%. Os métodos são simples, eficientes e podem ser utilizados em análises de rotina para o controle de qualidade de estatinas em comprimidos.
Title in English
Validation of methods for analysis of statins in tablets
Keywords in English
Analytical methods
Drug
Statins
Validation
Abstract in English
The statins are substances that inhibit the synthesis of cholesterol. There is no simple and low cost analytical methods for quantitative determination of pravastatin sodium, fluvastatin sodium, atorvastatin calcium and rosuvastatin calcium; the objective of this research was to develop, to validate and to compare the methods as high performance liquid chromatography and ultraviolet direct and derivative spectrophotometry for quantitative determination of statins in tablets. The chromatographic methods were carried out with a LiChrospherB RP-18 column with a mobile phase composed of methanol-water and pH adjusted to 3.0 with phosphoric acid. The spectrophotometric methods were validated using NaOH 0.1 M as solvent. The statistical analysis using tests t and F, did not show significant difference between the methods considering the 95% confidence level. The methods are simple, efficient and can be used in routine analyses for quality control of statins in tablets.
 
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Dissertacao.pdf (1.24 Mbytes)
Publishing Date
2009-02-11
 
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