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
| Autor: | Maria Luiza Pinheiro Costa Gomes, Scheilla Vitorino Carvalho de Souza |
|---|---|
| Jazyk: | English<br />Spanish; Castilian<br />Portuguese |
| Rok vydání: | 2010 |
| Předmět: | |
| Zdroj: | Química Nova, Vol 33, Iss 4, Pp 972-977 (2010) |
| Druh dokumentu: | article |
| ISSN: | 0100-4042 1678-7064 |
| DOI: | 10.1590/S0100-40422010000400038 |
| Popis: | 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 0.442 μg/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices. |
| Databáze: | Directory of Open Access Journals |
| Externí odkaz: |
|