Desenvolvimento e validação de metodologia analítica para a Determinação de vitaminas hidro e lipossolúveis em comprimidos Por cromatografia líquida de ultra eficiência (UPLC)

Abstract

The development and validation of analytical methodology focused on the quality control of medicines is an essential item for registration and marketing. In this work we developed and validated chromatographic methods for quantification of vitamins in multivitamins tablets by ultra performance liquid chromatography in three different analytical conditions: vitamins thiamin, riboflavin, nicotinamide and pyridoxine were well resolved in total analysis time of 2.5 minutes, by gradient elution, employing the column Acquity UPLC BEH Amide; analysis of tocopherol acetate was performed by isocratic elution, in total analysis time of 2.5 minutes, employing the column Acquity UPLC BEH C18 and cyanocobalamin was quantified in the same column employing other analytical conditions and the total analysis time was 2.5 minutes. Such analysis time was lower than those ones of similar methods reported in the literature. The three methods were subjected to validation tests and the results demonstrated that the proposed analytical techniques are specific, sensitive, accurate, exact and robust for the quantification of nicotinamide, pyridoxine, riboflavin, thiamine, and cyanocobalamin tocopherol acetate in multivitamins tablets. The work was fully developed in the quality control laboratory of a large pharmaceutical industry in the Distrito Agro-Industrial Anápolis (DAIA), in which the product is manufactured.