HPLC法测定硫糖铝片中蔗糖八硫酸酯的含量

Content Determination of Sucrose Octasulfate in Sucralfate Tablets by HPLC

目的建立可测定硫糖铝片中蔗糖八硫酸酯含量的高效液相色谱检测法。方法采用Agela VenusilXBP NH2柱,以0.8mol·L-1硫酸铵溶液(用磷酸调节pH值至3.5)-乙腈(83∶17)为流动相,流速为1.0mL·min-1,柱温为35℃,检测器为示差折光检测器。结果蔗糖八硫酸酯的线性范围为3.13～97.95mg·mL-1,r=1.0000。不同厂家批次硫糖铝片中蔗糖八硫酸酯的含量存在差异。结论国内首次采用高效液相色谱法对硫糖铝片中蔗糖八硫酸酯的含量进行了测定,该方法重复性好。

Objective To establish an HPLC method for the determination of sucrose octasulfate in sucralfate tablets. Methods The sample was separated on a column of Agela Venusil XBP NH2 which was eluted with 0. 8 mol·L-1 ammonium sulfate buffer （pH value is adjusted with phosphoric acid to 3.5） -acetonitrile （83 ~ 17）. The flow rate was 1.0mol·L-1 , and the column temperature was 35℃ detected by refractive index detector. Results The linear range of sucrose octasulfate was 3. 13 -97. 95 mol·L-1 （r = 1. 0000）. The content of sucrose octasulfate in sucralfate tablets was different in different samples. Conclusion HPLC method with good repeatability can be used to determine the content of sucrose octasulfate in sucralfate tablets.