HPLC法测定双嘧达莫分散片中双嘧达莫的含量及其均匀度

目的:建立双嘧达莫分散片中双嘧达莫含量及其均匀度的测定方法。方法:采用高效液相色谱法。色谱柱为Shimpack C18柱,流动相为磷酸氢二钠溶液-甲醇(25:75),流速为1.0mL·min-1,检测波长为288nm,进样量为20μL,柱温为25℃。结果:双嘧达莫检测浓度在16.07～80.35μg·mL-1(r=0.9999)范围内与峰面积积分值线性关系良好;低、中、高浓度的平均加样回收率分别为99.63%、98.82%、100.03%,RSD=1.0%(n=9)。结论:该法灵敏度高、重复性好、结果准确,可用于双嘧达莫分散片的质量控制。

Determination of Content and Content Uniformity of Dipyridamole in Dipyridamole Dispersible Tablets by HPLC

OBJECTIVE：To establish a method for determination of the content and the content uniformity of dipyridamole in Dipyridamole dispersible tablets.METHODS：HPLC method was adopted.The determination was performed on Shimpack C18 column with disodium hydrogen phosphate solution-methanol（25：75） as mobile phase at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 288 nm and injection volume was 20 μL.The column temperature was 25 ℃.RESULTS：The linear range of dipyridamole was 16.07～80.35 μg·mL-1（r=0.999 9）with an average recovery of 99.63%,98.82%,100.03%（RSD=1.0%,n=9）.CONCLUSION：The method is sensitive,precise and accurate.It can be used for the quality control of Dipyridamole dispersible tablets.