Validação de método para determinação de resíduos de amoxicilina aplicado à validação de limpeza em indústria farmacêutica de penicilânicos Validation of a method for determination of amoxicillin residues applied to cleaning validation process in penicillins pharmaceutical industry

• Main Authors: Maria Luiza Pinheiro Costa Gomes, Scheilla Vitorino Carvalho de Souza
• Format: Article
• Language: English
• Published: Sociedade Brasileira de Química 2010-01-01
• Series: Química Nova
• Subjects: amoxicillin; method validation; cleaning validation
• Online Access: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422010000400038

<abstract language="eng">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 &#956;g/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 0.442 &#956;g/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices.