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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 determine the contents of piperazine and related substances in dihydroartemisinin and piperaquine tablets by HPLC. Methods The chromatographic column was end capped (250 mm × 4.6 mm, 5 μm) with a gradient of acetonitrile-0.1% trichloroacetic acid-phosphoric acid (23:77:0.035) at a flow rate of 1.0 m L · min- 1, detection wavelength of 349 nm. Results The linear relationship between peak area and the concentration of 10 ~ 65μg · m L-1 of piperacillin was good (r = 0.9999). The recoveries were 100.6%, 99.2%, 98.8%, RSD 0.7%, 0.6% % (n = 3). The limit of quantification was 0.054 ng and the limit of detection was 0.016 ng. Conclusion The method is accurate, simple and rapid and suitable for the determination of piperacillin phosphate and its related substances in dihydroartemisinin-piperaquine tablets.