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Determination of triton X-100 in plasma-derived coagulation factor VIII and factor IX products by reversed-phase high-performance liquid chromatography
Authors:Karlsson Göran  Hinz Ann-Charlotte  Henriksson Elisabeth  Winge Stefan
Institution:Plasma R&D, Biovitrum, Stockholm, Sweden. goran.karlsson@biovitrum.com
Abstract:Plasma protein pools are often virus-inactivated by the solvent-detergent method, using tri-n-butyl phosphate and Triton X-100, followed by removal and determination of these compounds. We used reversed-phase high-performance liquid chromatography for the determination of Triton X-100 in coagulation factor VIII and factor IX products, Octonativ-M and Nanotiv, respectively (Pharmacia, Stockholm, Sweden). The chromatographic system included a C18 silica column and a linear acetonitrile gradient. The advantage of this method is the low detection limit (0.3 microg/ml) combined with detection at 280 nm, which gives a more stable baseline and has less interference from other compounds. As compared to other methods, where shorter wavelengths are used.
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