Development and validation of an ion-exchange chromatography method for heparin and its impurities in heparin products

Autor: Johan Viaene, Brompoj Prutthiwanasan, Sumate Thiangthum, Wolfgang Buchberger, Leena Suntornsuk, Yvan Vander Heyden
Rok vydání: 2014
Předmět:
Zdroj: Journal of Separation Science. 37:3195-3204
ISSN: 1615-9306
Popis: An anion-exchange liquid chromatography method for the determination of heparin and its impurities (dermatan sulfate and oversulfated chondroitin sulfate) was developed using chemometric-assisted optimization, including multivariate experimental design and response surface methodology. The separation of heparin, dermatan sulfate, and oversulfated chondroitin sulfate (Rs above 2.0) was achieved on a Dionex RF IC IonPac AS22 column with a gradient elution of 10-70% of 2.5 M sodium chloride and 20 mM Tris phosphate buffer (pH 2.1) at a flow rate of 0.6 mL/min and UV detection at 215 nm. Method validation shows good linearity (r > 0.99), acceptable precision (%relative standard deviations
Databáze: OpenAIRE
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