Analysis of heparin sodium by SAX/HPLC for contaminants and impurities

A chromatographic method was developed for the detection and quantification of the contaminant oversulfated chondroitin sulfate (OSCS) and the impurity dermatan sulfate in heparin active pharmaceutical ingredient (API). The HPLC analysis of heparin is carried out using a polymer-based strong anion e...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2009-04, Vol.49 (3), p.670-673
Main Authors: Trehy, Michael L., Reepmeyer, John C., Kolinski, Richard E., Westenberger, Benjamin J., Buhse, Lucinda F.
Format: Article
Language:English
Subjects:
Analysis
Analytical, structural and metabolic biochemistry
Anticoagulants - analysis
Biological and medical sciences
Chondroitin Sulfates - analysis
Chromatography, High Pressure Liquid
Chromatography, Ion Exchange
Dermatan sulfate
Dermatan Sulfate - analysis
Drug Contamination
Electrophoresis, Capillary
Fundamental and applied biological sciences. Psychology
General pharmacology
Glycosaminoglycan
Glycosaminoglycans - analysis
Heparin
Heparin - analysis
HPLC
Hydrogen-Ion Concentration
Indicators and Reagents
Medical sciences
Oversulfated chondroitin sulfate
Pharmacology. Drug treatments
Reference Standards
Reproducibility of Results
Spectrophotometry, Ultraviolet
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Summary:A chromatographic method was developed for the detection and quantification of the contaminant oversulfated chondroitin sulfate (OSCS) and the impurity dermatan sulfate in heparin active pharmaceutical ingredient (API). The HPLC analysis of heparin is carried out using a polymer-based strong anion exchange (SAX) column with gradient elution from 0.125M sodium chloride to 2.5M sodium chloride buffered mobile phase. The limit of detection (LOD) and limit of quantitation (LOQ) for the contaminant OSCS in heparin were determined to be 0.03% and 0.1%, respectively. The LOD and LOQ for dermatan sulfate, an impurity in heparin sulfate, were determined to be 0.1% and 0.8%, respectively. This manuscript is not a policy document and is not intended to replace either of the methods (capillary electrophoresis and NMR) currently required by the FDA.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2008.12.013