Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay
Braz. J. Pharm. Sci. (Online)
; 55: e18328, 2019. tab, graf
Article
en En
| LILACS
| ID: biblio-1039071
Biblioteca responsable:
BR40.1
Ubicación: BR40.1
ABSTRACT
Recombinant human interferon beta 1b (rhIFNß-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 rhIFNß-1b, contributing to improve the quality control and to ensure the efficacy of the biotherapeutic
Palabras clave
Texto completo:
1
Índice:
LILACS
Asunto principal:
Bioensayo
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Humanos
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Cromatografía de Fase Inversa
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Interferon beta-1b
Idioma:
En
Revista:
Braz. J. Pharm. Sci. (Online)
Asunto de la revista:
Farmacologia
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Teraputica
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Toxicologia
Año:
2019
Tipo del documento:
Article