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

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.