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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 C18MGⅡ,4.6 mm×1 0 0 mm,3μm)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 m L·min-1。结果双氢青蒿素在0.505 35~50.535μg(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。
OBJECTIVE To investigate the effect of the conversion of dihydroartemisinin (DHA) epimer on the content determination of dihydroartemisinin (DHA), a method for the determination of dihydroartemisinin was established. Methods HPLC-UV method: octadecylsilane bonded silica gel (CAPCELL PAK C18MGⅡ, 4.6 mm × 100 mm, 3 μm) was used as filler; acetonitrile-water (60:40) DMSO as a solvent; detection wavelength of 216 nm; flow rate of 0.6 m L · min-1. Results There was a good linear relationship between the injection volume of dihydroartemisinin and 0.505 35 ~ 50.535μg (r = 0.999 9). Conclusion Compared with the method of content determination contained in the second edition of Chinese Pharmacopoeia (2010 edition), the precision of the determination method and the accuracy of the determination results are improved. It provided a strong basis for the formulation of the quality standard of dihydroartemisinin in the Chinese Pharmacopoeia 2015 edition. The established method of determination of dihydroartemisinin has high precision and is simple, reliable and can be used for the content control of dihydroartemisinin.