示差折光高效液相色谱法测定复方胃蛋白酶颗粒中的糖

Determination of Sugars in Compound Saccharated Pepsin Granules by High Performance Liquid Chromatography with Refractive Index Detection

建立用示差折光高效液相色谱法测定复方胃蛋白酶颗粒中葡萄糖、蔗糖、麦芽糖含量的方法。选用色谱柱为Sugar-D,流动相为乙腈-水(78:22,V/V),流速为1.0mL/min,在室温条件下进样分析。结果表明:在该条件下,葡萄糖、蔗糖、麦芽糖能够较好分离,在0.50～10.00mg/mL范围内线性关系良好;葡萄糖回收率为94.3%～103.7%,蔗糖回收率为101.4%～105.1%;经不确定度评价,合成不确定度为1.92%,扩展不确定度为4.1%。该方法简单、准确、稳定、可靠,可用于复方胃蛋白酶颗粒中葡萄糖、蔗糖的含量测定。

A high performance liquid chromatography with refractive index detection（HPLC-RI） method was established for the simultaneous quantification of glucose,sucrose and maltose.The chromatographic separation was achieved on a Sugar-D column using a mixture of acetonitrile and water（V/V=78：22） as mobile phase at a flow rate of 1.0 mL/min.Under these conditions,glucose,sucrose and maltose could be well separated.A good linear relationship for each analyte was observed over the concentration range of 0.50-10.00 mg/mL.The spike recoveries of glucose and sucrose were 94.3%-103.7% and 101.4%-105.1% respectively.The results of uncertainty evaluation indicated that the combined standard uncertainty was 1.92% and the expanded uncertainty was 4.1%.The method was simple,accurate,stable,reproducible,and suitable for the practical determination of glucose,sucrose and maltose in compound saccharated pepsin granules.