| Registro completo |
| Provedor de dados: |
BJPS
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| País: |
Brazil
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| Título: |
Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay
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| Autores: |
Silva,Francielle Santos da
Walter,Maurício Elesbão
Xavier,Bruna
Perobelli,Rafaela Ferreira
Calegari,Guilherme Zanini
Cardoso,Douglas Franco
Perlin,Valquiria Guedes
Dalmora,Sérgio Luiz
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| Data: |
2019-01-01
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| Ano: |
2019
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| Palavras-chave: |
Recombinant human Interferon beta 1b
Biotechnology-derived medicine
Bioassay
Reversed-phase liquid chromatography
Size-exclusion liquid chromatography
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| Resumo: |
Recombinant human interferon beta 1b (rhIFNβ-1b) is clinically used to treat multiple sclerosis. A reversed-phase liquid chromatography (RP-LC) method was carried out on a Jupiter C4 column (250 mm × 4.6 mm i.d.). The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) in water, and the mobile phase B was acetonitrile with 0.1% TFA run at a flow rate of 1.0 mL/min. A size exclusion liquid chromatography (SE-LC) method was carried out on a BioSep-SEC-S 2000 column (300 mm × 7.8 mm i.d.). The mobile phase consisted of 1 mM monobasic potassium phosphate, 8 mM sodium phosphate dibasic and 200 mM sodium chloride buffer pH 7.4, run isocratically at a flow rate of 0.8 mL/min. Retention times were 31.87 and 17.78 min, and calibration curves were linear over the concentration range of 1-200 µg/mL (r2 = 0.9998) and 0.50-200 µg/mL (r2 = 0.9999), respectively, for RP-LC and SE-LC, with detection at 214 nm. Liquid chromatography (LC) methods were validated and employed in conjunction with the in vitro bioassay to assess the content/potency of rhIFNβ-1b, contributing to improve the quality control and to ensure the efficacy of the biotherapeutic.
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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=S1984-82502019000100571
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| Editor: |
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
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| Relação: |
10.1590/s2175-97902019000218328
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| Formato: |
text/html
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| Fonte: |
Brazilian Journal of Pharmaceutical Sciences v.55 2019
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| Direitos: |
info:eu-repo/semantics/openAccess
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