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复方蒿甲醚分散片的含量测定及其方法学研究

邢海艳,鲁素雅,金鹏,袁耀佐,金华   

  1. 淮安市食品药品检验所,淮安市食品药品检验所,淮安市食品药品检验所,江苏省食品药品监督检验研究院,淮安市食品药品检验所
  • 收稿日期:2018-10-11 修回日期:2018-10-11 出版日期:2019-04-25 发布日期:2019-04-25

A Method for Determining the Content of Artemether and Lumefantrine Dispersible Tablets and Methodology Study

  1. Huai''an Institute for Food and Drug Control,,,,
  • Received:2018-10-11 Revised:2018-10-11 Online:2019-04-25 Published:2019-04-25

摘要: 目的:建立并验证复方蒿甲醚分散片中蒿甲醚和苯芴醇的含量测定方法。方法:用十八烷基硅烷键合硅胶为填充剂;以离子对溶液-乙腈(70∶30)为流动相 A,离子对溶液-乙腈(30∶70)为流动相B,梯度洗脱,流速为1.3 mL·min-1;蒿甲醚检测波长为 210 nm,苯芴醇检测波长为 380 nm。结果:蒿甲醚和苯芴醇分别在0.051 0~0.611 9 mg·mL-1与0.299 2~2.392 mg·mL-1范围内呈良好的线性关系,相关系数分别为0.999 9和0.999 5,平均加标回收率分别为100.2%和99.6%。结论:该方法可同时测定分散片中蒿甲醚和苯芴醇的含量,简便、准确快速,分离度好,稳定性高,专属性强。

Abstract: Objective:To establish and validate the method for simultaneously determining the content of artemether and lumefantrine in the artemether and lumefantrine dispersible tablets.Methods: Using a stainless steel column (15 cm×3.9 mm) packed withparticles of silica gel which has been modified with chemically bonded octadeylsilyl groups (5 μm). 70 volumes of ion pair reagent and 30 volumes of acetonitrile R was the mobile phase A, 30 volumes of ion pair reagent and 70 volumes of acetonitrile R was the mobile phase B, and gradient elution. Operate with a flow rate of 1.3 mL per minute. As a detector using an ultraviolet spectrophotometer was set at a wavelength of about 210 nm for the first 28 minutes and then switch to about 380 nm. Results:There was a good linear relationship for artemether or lumefantrine in the range of 0.051 0~0.611 9 mg·mL-1 and 0.299 2~2.392 7 mg·mL-1, respectively. The correlation coefficients were 0.999 9 and 0.999 5, respectively. The average spiked recoveries were 100.2% and 99.6%, respectively. Conclusion:The method can simultaneously determine the content of artemether and lumefantrine in the artemether and lumefantrine dispersible tablets, and which is simple, accurate, rapid, good in separation, high in stability and strong in specificity.