Aspectos diferenciados no estudo de validação de métodos cromatográficos. Estudo de casos: seletividade em fitoterápicos e verificação de concentração de substância de referência vencida

Bahia Filho, Oscar

Palavras-chave: Validation of methods, HPLC, Herbal Extract, standard additions method, peak deconvolution.

Resumo: There is great availability of articles, documents and guidelines for the validation of analytical methods. However, due to enormous variability in the types of tests, the characteristics of new equipment and analytical matrices, in addition to defining the intended use, it is often necessary to develop different mechanisms that can meet the elements and regulatory compliance requirements. In this work, two cases are shown where the arrangement actions were necessary to obtain the desired result. At first, the quality assurance unit noted that the expiration date of the reference substance expired before completion of the validation study and in the second case, the need of determining the selectivity of a herbal material. Both cases were solved and the results shown in this work.

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