改进双氢青蒿素哌喹片中双氢青蒿素的溶出度测定方法

发布时间：2018-03-06 14:09

  本文选题：双氢青蒿素哌喹片　切入点：双氢青蒿素　出处：《中国药房》2017年15期 　论文类型：期刊论文

【摘要】：目的:改进双氢青蒿素哌喹片中双氢青蒿素的溶出度测定方法。方法:采用桨法进行溶出试验,以0.1 mol/L盐酸溶液为溶出介质,溶出介质体积为500 mL,转速为75 r/min,取样时间为45 min;样品前处理中加入3.6%氢氧化钠溶液的体积由原来的5mL改为20 mL,加入磷酸的体积由原来的0.2 mL改为0.7 mL。采用高效液相色谱法测定制剂中双氢青蒿素的溶出度:色谱柱为YMC-Pack ODS-A,流动相为0.02 mol/L磷酸氢二钠溶液(用磷酸调节p H为2.4)-乙腈(65∶35,V/V),流速为1.0 mL/min,检测波长为237 nm,柱温为30℃,进样量为20μL。结果:双氢青蒿素检测质量浓度线性范围为7.802~117.03μg/mL(r=0.999 9);定量限为2.0 ng,检测限为0.6 ng;精密度、重复性试验的RSD1.0%;回收率为99.18%~100.46%(RSD=0.45%,n=9)。3批样品中双氢青蒿素的平均溶出度分别为94.9%、77.9%、89.6%。结论:改进后的方法提高了其灵敏度、溶出度以及检测结果的准确性。
[Abstract]:Objective: to improve the dissolution of dihydroartemisinin in dihydroartemisinin piperaquine tablets. The volume of dissolved medium was 500mL, the rotational speed was 75rmin, the sampling time was 45min, the volume of 3.6% sodium hydroxide solution was changed from 5 mL to 20 mL, and the volume of phosphoric acid was changed from 0.2 mL to 0.7 mL. The dissolution of dihydroartemisinin in the preparation was determined by phase chromatography. The chromatographic column was YMC-Pack ODS-A, the mobile phase was 0.02 mol/L disodium hydrogen phosphate solution (adjusted by phosphoric acid to pH = 2.4- acetonitrile 65: 35V / V), the flow rate was 1.0 mL / min, the detection wavelength was 237nm, and the column temperature was 30 鈩，

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