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Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay
Silva, Francielle Santos da; Walter, Maurício Elesbão; Xavier, Bruna; Perobelli, Rafaela Ferreira; Calegari, Guilherme Zanini; Cardoso, Douglas Franco; Perlin, Valquiria Guedes; Dalmora, Sérgio Luiz.
  • Silva, Francielle Santos da; Federal University of Santa Maria. Postgraduate Program in Pharmaceutical Sciences. Santa Maria. BR
  • Walter, Maurício Elesbão; Federal University of Santa Maria. Postgraduate Program in Pharmaceutical Sciences. Santa Maria. BR
  • Xavier, Bruna; Federal University of Santa Maria. Postgraduate Program in Pharmaceutical Sciences. Santa Maria. BR
  • Perobelli, Rafaela Ferreira; Federal University of Santa Maria. Postgraduate Program in Pharmaceutical Sciences. Santa Maria. BR
  • Calegari, Guilherme Zanini; Federal University of Santa Maria. Department of Industrial Pharmacy. Santa Maria. BR
  • Cardoso, Douglas Franco; Federal University of Santa Maria. Department of Industrial Pharmacy. Santa Maria. BR
  • Perlin, Valquiria Guedes; Federal University of Santa Maria. Department of Industrial Pharmacy. Santa Maria. BR
  • Dalmora, Sérgio Luiz; Federal University of Santa Maria. Department of Industrial Pharmacy. Santa Maria. BR
Braz. J. Pharm. Sci. (Online) ; 55: e18328, 2019. tab, graf
Article in English | LILACS | ID: biblio-1039071
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
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Full text: Available Index: LILACS (Americas) Main subject: Biological Assay / Humans / Chromatography, Reverse-Phase / Interferon beta-1b Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2019 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Santa Maria/BR

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Full text: Available Index: LILACS (Americas) Main subject: Biological Assay / Humans / Chromatography, Reverse-Phase / Interferon beta-1b Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2019 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Santa Maria/BR