[ Kwaliteitscheck heparine ]

HPLC-NMR onthult vervuilingen

17 december 2009 Tim Snoek 25 reacties

Onderzoekers hebben een nieuwe methode ontwikkeld om vervuiling in batches heparine te identificeren. Ze schrijven dit in Analytical Chemistry.

Heparine is een antistollingsmedicijn dat wordt gebruikt bij hartoperaties en in de behandeling van taaislijmziekte en acute trombose. De meeste heparine is afkomstig uit China, waar het molecuul wordt geïsoleerd uit varkensdarmen. In 2008 leidde verontreinig met overgesulfateerd chondroïtinesulfaat (OSCS), afkomstig uit het kraakbeen van de varkens en bijgemengd door de fabrikant, tot een groot schandaal. In Amerika overleden hier meer dan 100 mensen aan.

 

De nieuwe methode koppelt HPLC aan NMR. De onderzoekers laten zien dat de methode in staat is dermataansulfaat, chondroïtinesulfaat A, heparine en OSCS van elkaar te scheiden en te identificeren.

 

Er bestaan al technieken om verontreinigingen in heparine te ontdekken, zoals capillaire elektroforese en een potentiometrische wegwerpsensor. De onderzoekers geven toe dat HPLC-NMR geen geschikte techniek voor routinematige kwaliteitscontrole is. Wel zien ze hun techniek een rol spelen in het identificeren van onbekende pieken (vervuilingen) die bij simpelere methoden aan het licht komen.

 

Bron: separationsNOW.com



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