Data/hora: 06/06/2024 00:39:36

Provedor de dados: | 60
País: | Brazil
Título: | A fully validated microbiological assay for daptomycin injection and comparison to HPLC method
Autores: | Christ,Ana Paula; Machado,Mariana Souto; Ribas,Karla Giacomelli; Schwarzbold,Alexandre Vargas; Silva,Cristiane de Bona da; Adams,Andréa Inês Horn.
Data: | 2015-12-01
Ano: | 2015
Palavras-chave: | Daptomycin/determination; Daptomycin injection/quality control; Turbidimetric microbiological assay/quantitative analysis.
Resumo: | abstract Daptomycin (DPT) was the first lipopeptide antibiotic available for commercialization. It is active against gram-positive bacteria, including resistant strains. This work aimed to develop and validate a turbidimetric microbiologic assay to determine daptomycin in an injectable form. A 3x3 design was employed, at concentrations of 1, 2 and 4.0 µg/mL. The microorganism test used was Staphylococcus aureus ATCC 6538p, and Antibiotic Medium 3 was used as the culture medium. Method validation demonstrated that the bioassay was linear (r=0.9995), precise (RSD=2.58%), accurate (recovery 100.48± 2.11%), and robust. Degradation kinetics was also performed in an alkaline medium, indicating that daptomycin degradation follows first order kinetics under these conditions. The analyses of degraded solutions showed that daptomycin degradation products do not possess bactericidal activity. The bioassay was compared to HPLC method that was previously developed and no significant difference was found between them (p&gt;0.05). The method proved to be appropriate for daptomycin injection quality control.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400775
Editor: | Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação: | 10.1590/S1984-82502015000400003
Formato: | text/html
Fonte: | Brazilian Journal of Pharmaceutical Sciences  v.51 n.4 2015
Fonte: | info:eu-repo/semantics/openAccess