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目的建立高效液相色谱法测定异山梨醇含量。方法色谱柱为Kromasil C18(4.6 mm×250 mm,5μm),流动相为甲醇-水(50∶50),流速为1.0 mL·min-1,ELSD载气流速为2.5 mL·min-1,检测器飘移管温度为30℃。结果异山梨醇在100～300μg·mL-1浓度的对数与峰面积对数有良好的线性关系(R2=0.999 1,n=5),且该方法的平均回收率为99.8%,RSD为0.08%(n=9)。结论该方法简便,结果准确,可用于异山梨醇含量的测定。
Objective To establish a HPLC method for the determination of isosorbide. Methods The chromatographic column was Kromasil C18 (4.6 mm × 250 mm, 5 μm). The mobile phase was methanol-water (50:50), the flow rate was 1.0 mL · min-1 and the flow rate of ELSD was 2.5 mL · min- Device drift tube temperature is 30 ℃. Results The logarithm of isosorbide at a concentration of 100-300μg · mL-1 had a good linear relationship with the logarithm of peak area (R2 = 0.999 1, n = 5), and the average recovery of this method was 99.8% with RSD 0.08% (n = 9). Conclusion The method is simple and accurate and can be used for the determination of isosorbide content.