Development and validation of a capillary zone electrophoresis method for assessment of recombinant human granulocyte colony-stimulating factor in pharmaceutical formulations and its correlation with liquid chromatography methods and bioassay.
J Chromatogr B Analyt Technol Biomed Life Sci
; 877(24): 2471-6, 2009 Aug 15.
Article
em En
| MEDLINE
| ID: mdl-19560410
A capillary zone electrophoresis (CZE) method was validated for the analysis of recombinant human granulocyte colony-stimulating factor (rhG-CSF) and performed on a fused-silica capillary, with detection at 195 nm. The background electrolyte solution consisted of 50 mM sodium tetraborate solution at pH 9. The method was linear in the concentration range of 1-200 microg/mL and the limit of quantitation (LOQ) was 1 microg/mL, with acceptable validation parameters. The method was applied for the analysis of pharmaceutical formulations, and the results were correlated to the reversed-phase HPLC method (RP-HPLC), size-exclusion HPLC method (SE-HPLC) and in vitro bioassay method.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fator Estimulador de Colônias de Granulócitos
/
Eletroforese Capilar
Tipo de estudo:
Evaluation_studies
Limite:
Humans
Idioma:
En
Revista:
J Chromatogr B Analyt Technol Biomed Life Sci
Assunto da revista:
ENGENHARIA BIOMEDICA
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Holanda