Conceitos de validação de metodos cromatograficos, aplicados na determinação de Omeprazol e impurezas em capsulas e comprimidos

AUTOR(ES)
DATA DE PUBLICAÇÃO

2004

RESUMO

To guarantee that an analytical procedure gives reliable, exact and interpretable information about a sample, it should be submitted to an evaluation caIled validation. The fundamental objective of the present work is to describe the main concepts and parameters of validation used in the analysis of drugs by high performance liquid chromatography (HPLC), showing the differences and similarities between the directives established by different regulatory agencies of Brazil and of other countries, to arrange the validation parameters in a logical sequence and to give suggestions with respect to the steps necessary in a validation processo In this work an approach was also developed and validated for the determination of Omeprazol in capsules and tablets, applying the validation concepts and using statistical tools to express the results of precision and accuracy. The values of the detection limit (LD) and the quantification limit (LQ) obtained showed that, in chromatographic analyses, the best method is that based on the use of the parameters obtained from the analytical curve, which are statisticaIly reliable. It was shown that smaller values of LD were obtained by the visual approach and by the method using the signal-to-noise ratio. These values may reflect a subjective evaluation, prone to errors and large variations. This was confirmed by showing that these methods result in values, which falI outside the linear range of concentration of the method.

ASSUNTO(S)

validação de metodo omeprazol

ACESSO AO ARTIGO

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