Determination of Main Carbohydrate Residues in Dextran 40 by HPLC-RID Method
OBJECTIVE To establish a high performance liquid chromatography-refractive index detector method for the determi-nation of main potential carbohydrate residues fructose and sucrose concentration in dextran 40 raw materials from different of production processes,analyze the differences in carbohydrate residues in dextran 40 produced by different manufactures,and provide a reference for the quality evaluation of related drugs and the formulation or edit of national drug standards.METHODS Isocratic elution was performed on a ZORBAX-NH2 column.Mobile phase consisted of 75％acetonitrile and 25％water at a flow rate of 1.0 mL·min-1.RID was used as detector.The detector temperature and column temperature was maintained at 40 ℃ and the injection volume was 50μL.RESULTS Sucrose was not detected in all batches of dextran 40.Fructose residue could only be detected in dextran 40 which u-sing alcohol precipitation production process,and the content was 0.005％-0.14％.No fructose residue was detected in the dextran 40 of manufacturer B using membrane filtration method.CONCLUSION The HPLC-RID method is established to determine the con-tent of fructose and sucrose in dextran 40.The method has strong specificity,high sensitivity,good stability and simple operation.The amount of fructose residual in dextran 40 produced by different processes varies greatly.The fructose residual in the raw material of dextran 40 obtained by membrane filtration is significantly lower than that by alcohol precipitation,it is necessary to control the fructose residue in the quality standard.
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