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目的:建立以HPLC法测定复方丹参渗透泵型控释片中丹参酮ⅡA的含量的方法。方法:色谱柱为Hy-persil ODS C18柱(4.6mm×250mm,5μm),流动相为甲醇:水(85:15);流速为1.0mL.min-1;检测波长为270nm。结果:丹参酮IIA在1.6～14.4μg.mL-1浓度范围之间线性良好,r=0.9998;平均回收率为98.41%,RSD=1.64%。结论:本法准确、灵敏、重现性好、操作简便,主峰与杂质峰分离完全,可用于复方丹参渗透泵型控释片的质量控制。
Objective: To establish a method for the determination of tanshinone II A in compound Danshen osmotic pump controlled release tablets by HPLC. Methods: The column was Hy-persil ODS C18 column (4.6mm×250mm, 5μm). The mobile phase was methanol:water (85:15). The flow rate was 1.0mL.min-1. The detection wavelength was 270nm. RESULTS: The tanshinone IIA had a good linearity in the concentration range from 1.6 to 14.4 μg.mL-1, r=0.9998. The average recovery was 98.41% and the RSD was 1.64%. Conclusion: This method is accurate, sensitive, reproducible, easy to operate, complete separation of main peak and impurity peak, and can be used for quality control of compound Danshen osmotic pump type controlled release tablets.