论文部分内容阅读
目的研究不同对照品对高效凝胶色谱法(HPGPC)测定右旋糖酐铁原料及制剂分子量的影响。方法分别采用右旋糖酐和普鲁兰为对照品,以Shodex SB-806M HQ(7.8 mm×300 mm)凝胶柱,对7个不同厂家生产的12批样品进行分析。结果以普鲁兰对照品测得的右旋糖酐铁峰位分子量比用右旋糖酐对照品测得的结果低。结论不同对照品对HPGPC测定右旋糖酐铁分子量的影响较大,对照品的选择直接影响测定结果的准确性。
Objective To study the effects of different reference materials on the determination of iron dextran and the preparation molecular weight by high performance gel permeation chromatography (HPGPC). Methods Dextran and pullulan were used as reference materials and 12 batches of samples from 7 different manufacturers were analyzed by using Shodex SB-806M HQ (7.8 mm × 300 mm) gel column. Results The molecular weight of iron dextran peak measured with pullulan control was lower than that of dextran reference substance. Conclusion Different reference products have a great influence on the determination of iron dextran by HPGPC. The choice of reference substance has a direct impact on the accuracy of the determination results.