HPLC法测定青蒿琥酯及其片剂的含量

HPLC determination of artesunate and its tablets

目的:建立青蒿琥酯及其片剂含量测定的高效液相色谱法。方法:采用 Platinum Alhech C_(18)柱(250mm×4.6mm,5μm),以水-乙腈(45:55,用稀醋酸调节 pH 至4.5)为流动相,流速为1.0mL·min^(-1),外标法测定,检测波长为210nm。结果:线性范围为5～50μg,r=0.9999;青蒿琥酯片的平均加样回收率(n=3)分别为98.9%(RSD=0.78%),99.9%(RSD=0.53%)和100.2%(RSD=0.14%);最低检测限为0.23μg;最低定量限为0.78μg。结论:该法准确、快速、简便,适用于青蒿琥酯及其片剂的含量测定。

Objective：To establish an HPLC method for assay of artesunate and its tablets. Method：The separation was performed on a Platinum Alltech C18 column （250 mm ×4. 6 mm, 5 μm）. The mobile phase was composed of water - acetonitrile （45： 55, pH 4. 5）. The flow rate was 1.0 mL ·min^-1. The detection wavelength was 210 nm. Results ：The calibration curve was linear in the range of 5 - 50 μg, r = 0. 9999. The average recoveries （ n = 3 ） were 98.9% （ RSD =0.78% ） ,99.9% （ RSD = 0. 53% ） and 100. 2% （ RSD = 0. 14% ） respectively. The LOD was 0. 23 μg. The LOQ was 0. 78 μg. Conclusion：The method is simple, rapid, accurate and is suitable for the determination of artesunate and its tablets.