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.
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.
Dalmora
Sergio Luiz
SL
Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil. sdalmora@terra.com.br
D'Avila
Felipe Bianchini
FB
da Silva
Lucélia Magalhães
LM
Bergamo
Ana Cláudia
AC
Zimmermann
Estevan Sonego
ES
D001681:Biological Assay / Q000379:methods; D002460:Cell Line; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D019075:Electrophoresis, Capillary / Q000379:methods*; D016179:Granulocyte Colony-Stimulating Factor / Q000032:analysis* / Q000494:pharmacology; D006801:Humans; D011994:Recombinant Proteins / Q000032:analysis / Q000494:pharmacology
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor