CONSIDERATIONS AND PRACTICAL IMPLICATIONS OF THE GUIDE FOR VALIDATION AND ANALYTICAL QUALITY CONTROL OF DRUGS IN FEED AND VETERINARY DRUGS

Author(s)

Susanne Rath ^[1] ; Mónica Johanna Martínez-Mejia ^[2] ; Cláudia Hoffmann Kowalski Schröder ^[3]

Affiliation

^[1] Universidade Estadual de Campinas. Instituto de Química. Departamento de Química Analítica - Brasil

^[2] Universidade Estadual de Campinas. Instituto de Química. Departamento de Química Analítica - Brasil

^[3] Universidade Estadual de Campinas. Instituto de Química. Departamento de Química Analítica - Brasil

• Document type: Journal article
• Source: Química Nova; v. 38, n. 5, p. 697-708, 2015-06-00.

Abstract

<p>Recently, the Brazilian Ministry of Agriculture, Livestock and Supply (MAPA) published a validation and analytical quality control guide called the “Guia de Validação e Controle de Qualidade Analítica – Fármacos em Produtos para Alimentação Animal e Medicamentos Veterinários”, in order to guide officers and accredited laboratories in the validation of analytical methods for the quality control of veterinary medicines, drug contaminants in feed and depletion studies (residues of drugs in biological matrices). The aim of this study was to present a critical evaluation of the concepts and procedures defined in this document. The Guide was applied for the validation of chromatographic methods intended to be used for the quantification of antimicrobial and antiparasitic drugs in veterinary medicines. Methods for the determination of ivermectin, abamectin, sulfadiazine, sulfadimethoxine, sulfaquinoxaline, streptomycin, dihydrostreptomycin and florfenicol were validated using the Guide. Each validation parameter was evaluated and discussed. A total of 55 samples of veterinary drugs were analyzed.</p> (AU)

• FAPESP's process: 09/10443-1 - Development and validation of analytical methods for quality control of veterinary drugs
• Grantee: Susanne Rath
• Support Opportunities: Regular Research Grants
• FAPESP's process: 13/09543-7 - Residues of veterinary drugs in the environment
• Grantee: Susanne Rath
• Support Opportunities: Research Projects - Thematic Grants