HPLC测定双氢青蒿素哌喹片中的磷酸哌喹及有关物质

Determination of piperaquine phosphate and the related substances in Dihydroartemisinin and piperaquine phosphate tablets by HPLC

目的采用HPLC法测定双氢青蒿素哌喹片中的磷酸哌喹及有关物质。方法色谱柱为Merck Purospher Star LP RP-18 endcapped（250 mm×4.6 mm,5μm）,流动相为乙腈-0.1%三氯乙酸溶液-磷酸（23∶77∶0.035）,流速1.0 m L·min-1,检测波长349 nm。结果磷酸哌喹10-65μg·m L-1与峰面积的线性关系良好（r=0.9999）,加样回收率分别为100.6%、99.2%、98.8%,RSD分别为0.7%、0.6%、0.3%（n=3）,定量限为0.054 ng,检出限为0.016 ng。结论所用方法准确、简便、快速,适用于双氢青蒿素哌喹片中磷酸哌喹的含量测定及其有关物质的检查。

OBJECTIVE To detect the contents of piperaquine phosphate and related substances in Dihydroartemisinin and pipera- quine phosphate tablets by HPLC. METHODS Merck Purospher STAR LP RP - 18 endcapped（250 mm ×4. 6 mm,5 μn） column was used with UV detection at 349 nm, and the mobile phase consisted of acetonitrile ,0.1% trichloroacetate and phosphate（ 23 ： 77 ： 0. 035 ）. The flow rate was 1.0 mL·min - 1. RESULTS The calibration curve was linear （ r = 0. 9999 ） within the range of 10 - 65 p,g. mL -1for piperaquine phosphate. The average recovery was 100.6% ,99.2% ,98.8% with RSD = 0.7% ,0.6% ,0.3% （ n = 3 ）. Quanti- tation limit was 0.054 ng, and detection limit was 0.016 rig. CONCLUSION This method is simple, rapid, accurate and effective for the content determination and testing piperaquine phosphate and related substances in Dihydroartemisinin and piperaquine phosphate tablets.