复方蒿甲醚分散片的含量测定及其方法学研究

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

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. 392mg·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。

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(5μm).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.