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改进双氢青蒿素哌喹片中双氢青蒿素的溶出度测定方法
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| 篇名： | 改进双氢青蒿素哌喹片中双氢青蒿素的溶出度测定方法 |
| TITLE： | |
| 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5 mL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pH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20 μL。结果：双氢青蒿素检测质量浓度线性范围为7.802～117.03 μg/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RSD＜1.0％；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 detection method for the dissolution of dihydroartemisinin in Dihydroartemisinin and piperaquine phosphate tablets. METHODS： The dissolution experiment adopted paddle method using 0.1 mol/L hydrochloric acid solution 500 mL as solvent with rotating speed of 75 r/min and sampling time of 45 min. In sample pre-treatment， the volume of 3.6％ sodium hydroxide solution was increased from 5 mL to 20 mL， and that of phosphoric acid was increased from 0.2 mL to 0.7 mL. HPLC was adopted to determine the dissolution of dihydroartemisinin. The determination was performed on YMC-Pack ODS-A column with mobile phase consisted of 0.02 mol/L disodium hydrogen phosphate solution（pH adjusted to 2.4 using phosphoric acid）-acetonitrile （65 ∶ 35，V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 237 nm，and column temperature was 30 ℃. The sample size was 20 μL. RESULTS： The linear range of dihydroartemisinin were 7.802-117.03 μg/mL（r＝0.999 9）. The limit of quantitation was 2.0 ng， and the limit of detection was 0.6 ng. RSDs of precision and reproducibility tests were all lower than 1.0％. The recoveries were 99.18％-100.46％ （RSD＝0.45％，n＝9）. Average dissolutions of dihydroartemisinin in 3 batches of samples were 94.9％， 77.9％， 89.6％， respectively. CONCLUSIONS： Improved method enhance the accuracy for the limit of sensitivity， dissolution and detection results. |
| 期刊： | 2017年第28卷第15期 |
| 作者： | 张勉，李超 |
| AUTHORS： | ZHANG Mian，LI |
| 关键字： | 双氢青蒿素哌喹片；双氢青蒿素；溶出度测定；方法改进 |
| KEYWORDS： | Dihydroartemisinin and piperaquine phosphate tablets；Dihydroartemisinin；Dissolution determination；Method improvement |
| 阅读数： | 457 次 |
| 本月下载数： | 8 次 |
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