| Registro completo |
| Provedor de dados: |
BJPS
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| País: |
Brazil
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| Título: |
A fully validated microbiological assay for daptomycin injection and comparison to HPLC method
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| Autores: |
Christ,Ana Paula
Machado,Mariana Souto
Ribas,Karla Giacomelli
Schwarzbold,Alexandre Vargas
Silva,Cristiane de Bona da
Adams,Andréa Inês Horn
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| Data: |
2015-12-01
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| Ano: |
2015
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| Palavras-chave: |
Daptomycin/determination
Daptomycin injection/quality control
Turbidimetric microbiological assay/quantitative analysis.
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| 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>0.05). The method proved to be appropriate for daptomycin injection quality control.
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| Tipo: |
Info:eu-repo/semantics/article
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| Idioma: |
Inglês
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| Identificador: |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400775
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| Editor: |
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
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| Relação: |
10.1590/S1984-82502015000400003
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| Formato: |
text/html
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| Fonte: |
Brazilian Journal of Pharmaceutical Sciences v.51 n.4 2015
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| Direitos: |
info:eu-repo/semantics/openAccess
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