VALIDACAO DE METODO PARA DETERMINACAO DE RESIDUOS DE AMOXICILINA APLICADO VALIDACAO DE LIMPEZA EM INDUJSTRIA FARMACEUTICA DE PENICILANICOS

摘要

The aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. Linearity was demonstrated between 2.5 and 17.5 μg/mL, without matrix effects. Mean recoveries ranged from 84.00 to 103.74% and the relative standard deviation under repetitivity and within-reproducibility conditions were from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. The theoretical limits of detection and quantification were 0.133 and 0.442μg/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices.