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

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 877, Issue 24, 2009, Pages 2471-2476

  Dalmora, Sergio Luiz ^a   D'Avila, Felipe Bianchini ^a   Silva, Lucélia Magalhães da ^a   Bergamo, Ana Cláudia ^a   Zimmermann, Estevan Sonego ^a  

^a FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

Author keywords

Capillary zone electrophoresis; GNFS 60 cell culture assay; Liquid chromatography; Recombinant human granulocyte colony stimulating factor; Validation

Indexed keywords

BACK GROUND ELECTROLYTE; CAPILLARY ZONE ELECTROPHORESIS; CONCENTRATION RANGES; FUSED-SILICA CAPILLARIES; GNFS-60 CELL CULTURE ASSAY; GRANULOCYTE-COLONY STIMULATING FACTOR; HPLC METHOD; IN-VITRO; LIMIT OF QUANTITATIONS; PHARMACEUTICAL FORMULATION; RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR; REVERSED-PHASE HPLC METHOD; RP-HPLC; SODIUM TETRABORATE; VALIDATION; VALIDATION PARAMETERS;

ANIMAL CELL CULTURE; CAPILLARY ELECTROPHORESIS; CELL CULTURE; CELL MEMBRANES; CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; DRUG PRODUCTS; ELECTROCHEMISTRY; ELECTROLYTES; FUSED SILICA; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PRESSURE LIQUID CHROMATOGRAPHY; LIQUIDS; SILICA; SODIUM;

BIOASSAY;

BORATE SODIUM; ELECTROLYTE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SILICON DIOXIDE;

ANIMAL CELL; ARTICLE; CAPILLARY ZONE ELECTROPHORESIS; CONTROLLED STUDY; DRUG FORMULATION; GEL PERMEATION CHROMATOGRAPHY; IN VITRO STUDY; LIQUID CHROMATOGRAPHY; NONHUMAN; PH MEASUREMENT; PRIORITY JOURNAL; QUALITY CONTROL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

BIOLOGICAL ASSAY; CELL LINE; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; ELECTROPHORESIS, CAPILLARY; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; RECOMBINANT PROTEINS;

EID: 67650725372     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2009.06.011     Document Type: Article

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