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Abstract
A High Performance Ion Chromatographic (HPIC) method for the quantitation of glucose, isomaltose and maltose in hydroxyethyl starches is described. Hydroxethyl Starches are a family of amylopectin which has been ethoxylated. During the manufacturing and the shelf life of the finished product solutions, mono- and di-saccharide units may be generated as degradation products from the hydrolysis of starch. Those found are maltose from the 1,4-linkage, isomaltose from the 1,6-linkage, and glucose. These are non-toxic substances but are of concern if high levels are administered to diabetic patients. Separations were performed using anion exchange chromatography with a Carbopac PA1 column and 100 mM sodium hydroxide as the mobile phase. The method was found to be linear over the range of 0.1 to 20.0 μg/mL for glucose, 0.2 to 20.0 μg/mL for isomaltose, and 0.5 to 20.0 μg/mL for maltose. The limits of quantitation were found to be 0.5 μg/mL for glucose and isomaltose and 1.0 μg/mL for maltose. Method precision of 2% RSD was found at the limit of quantitation for each component.