目的 考察双氢青蒿素(DHA)差向异构体转化现象对含量测定结果 的影响,建立了双氢青蒿素的含量测定方法。方法 采用HPLC-UV法:用十八烷基硅烷键合硅胶(CAPCELL PAK C18 MGⅡ,4.6 mm×100 mm,3 μm)为填充剂;以乙腈-水(60∶40)为流动相;选用二甲亚砜作为溶剂;检测波长为216 nm;流速为0.6 mL·min-1。结果 双氢青蒿素在0.505 35～50.535 μg(r=0.999 9)内进样量与峰面积呈良好的线性关系。结论 与《中国药典》2010年版二部收录的含量测定方法相比,测定方法的精密度和测定结果 的准确性得到良好改善。为2015年版《中国药典》双氢青蒿素质量标准的制定提供有力依据。所建立双氢青蒿素含量测定方法精密度高,方法简便、可靠,可用于双氢青蒿素的含量控制。
Abstract
OBJECTIVE To establish the content determination method for dihydroartemisinin(DHA). METHODS The high performance liquid chromatography was carried out on a column packed with octadecylsilane bonded silica gel (CAPCELL PAK C18 MGⅡ,4.6 mm×100 mm,3 μm), using a mixture of acetonitrile-water (60∶40) as the mobile phase.Dimethylsulfoxide was chosen as the solvent for the DHA bulk drug.The detection wavelength was set at 216 nm and the flow rate was 0.6 mL·min-1. RESULTS The linear range of DHA calibration curve was 0.505 35-50.535 μg (r=0.999 9). CONCLUSION Compared with the method included in ChP, the precision of the established content determination method is improved significantly. It is accurate, reliable, convenient, and has good reproducibility for content determination of DHA.
关键词
双氢青蒿素 /
高效液相色谱法 /
差向异构体 /
二甲亚砜 /
含量测定
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Key words
dihydroartemisinin /
HPLC /
epimer /
dimethyl sulfoxide /
content determination
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中图分类号：
R917
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参考文献
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