Validation of a size-exclusion LC method and assessment of rhepo in pharmaceutical formulations by liquid chromatography and biological assay

Journal of Liquid Chromatography and Related Technologies

Volumn 32, Issue 10, 2009, Pages 1392-1406

  Ferretto, Ricardo MacHado ^a   Leal, Diogo Paim ^a   Da Silva, Lucélia Magalhães ^a   Nogueira, Daniele Rubert ^a   Dalmora, Sérgio Luiz ^a  

^a FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

Author keywords

Erythropoietin; Pharmaceutical formulations; Size exclusion liquid chromatography; Validation

Indexed keywords

BIOLOGICAL ASSAYS; CHROMATOGRAPHIC SEPARATIONS; ERYTHROPOIETIN; LIMITS OF DETECTION AND QUANTITATION; METHOD VALIDATIONS; MOBILE PHASE; PHARMACEUTICAL DOSAGE FORMS; PHARMACEUTICAL FORMULATION; PHARMACEUTICAL FORMULATIONS; PHOTODIODE ARRAYS; POTASSIUM PHOSPHATE; RETENTION TIME; SERUM ALBUMIN; SIZE EXCLUSION; SIZE EXCLUSION LIQUID CHROMATOGRAPHY; SODIUM PHOSPHATE; THERAPEUTIC EFFICACY; VALIDATION;

BIOASSAY; CHROMATOGRAPHIC ANALYSIS; DRUG PRODUCTS; HIGH PRESSURE LIQUID CHROMATOGRAPHY; LIQUIDS; PHOSPHATES; POTASSIUM; QUALITY CONTROL; QUALITY FUNCTION DEPLOYMENT; SODIUM; SODIUM CHLORIDE; TOTAL QUALITY MANAGEMENT;

SIZE EXCLUSION CHROMATOGRAPHY;

BUFFER; DISODIUM HYDROGEN PHOSPHATE; POTASSIUM DIHYDROGEN PHOSPHATE; RECOMBINANT ERYTHROPOIETIN; SERUM ALBUMIN; SODIUM CHLORIDE;

ACCURACY; ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; BIOASSAY; COLUMN CHROMATOGRAPHY; CONTROLLED STUDY; DIODE; DRUG DETERMINATION; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG FORMULATION; DRUG POTENCY; DRUG RETENTION; FEMALE; FLOW RATE; GEL PERMEATION CHROMATOGRAPHY; MOUSE; NONHUMAN; PH; QUALITY CONTROL; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 70349490790     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070902900327     Document Type: Article

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