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Published on: March 13, 2014
Determination of the stabilizer sucrose in a plasma-derived antithrombin process solution by hydrophilic interaction
Göran Karlsson1, Ann-Charlotte Hinz, Stefan Winge
1Octapharma AB, SE-11275 Stockholm, Sweden.
Abstract:
Hydrophilic interaction chromatography (HILIC) is used for the quantitation of sucrose in the range of 10-100 micro g/mL. A poly-2-hydroxyethylaspartamide column is eluted with 25% water-75% acetonitrile, and evaporative light scattering is utilized for detection. A process sample of antithrombin (Atenativ) from Octapharma AB (Stockholm, Sweden) containing 20% sucrose is analyzed. The precision for this high-performance liquid chromatographic method is a percent relative standard deviation (%RSD) of 4, limit of detection (s/n=3) of 1 microg/mL, and mean recovery of spiked samples of 101% (RSD% of 3, n=6). Analysis time is 10 min/sample. Glucose, fructose, sodium citrate, sodium phosphate, Triton X-100, and tri-n-butyl phosphate do not interfere with the method.
