HPLC法测定青蒿素哌喹片中青蒿素的溶出度

目的：采用HPLC法建立青蒿素哌喹片中青蒿素溶出度测定方法。方法：采用桨法，以含0.5%十二烷基硫酸钠的磷酸盐缓冲液为溶出介质，转速为75 r·min^-1，45 min取样。采用Shim-pack VP-C₁₈（150 mm×0.46 mm，5 μm）色谱柱，以乙腈-水（50：50）为流动相，柱温为30 ℃，流速为1.0 mL·min^-1，检测波长为210 nm。结果：青蒿素浓度在0.025~0.5 mg·mL^-1范围内线性关系良好（r=0.9996），平均回收率（n=9）为100.1%。3批样品在45 min的溶出度均超过标示量的70%。结论：本方法准确、可靠，灵敏度高，适用于青蒿素哌喹片中青蒿素溶出度的检测。

Objective: To establish a method for the dissolution determination of artemisinin in artemisinin and piperaquine tablets by HPLC. Methods: The paddle method was adopted,using 500 mL of 0.5% sodium dodecyl sulfate solution in phosphate BS (pH 6.8) as solvent,the rotation speed at 75 r·min^-1.The chromatographic condition was as follows:the Shim-pack VP-C₁₈(150 mm×0.46 mm,5 μm)column was used,the mobile phase was composed of acetonitrile-water (50:50) at the flow rate of 1.0 mL·min^-1,the detection wavelength was 210 nm and the column temperature was 30 ℃. Results: The calibration curve showed a good linearity in the range of 0.025-0.5 mg·mL^-1(r=0.9996).The average recovery (n=9) was 100.1%.Three batches of samples were detected using this method and the dissolution results were above 70% at 45 min. Conclusion: The method is accurate,reliable and sensitive,and can be applied to the dissolution determination of artemisinin in artemisinin and piperaquine tablets.

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