DAD与ELSD在青蒿素哌喹片含量及溶出度测定方法比较  

Comparison of DAD and ELSD for Content and Dissolution of Artemisinin and Piperaquine Tablets

作　　者：邓映明 张雁 古炳明 Deng Yingming;Zhang Yan;Gu Bingming(Meizhou Institute for Food and Drug Control,Meizhou 514071,China)

机构地区：[1]梅州市食品药品监督检验所,广东梅州514017

出　　处：《广东化工》2023年第20期157-159,189,共4页Guangdong Chemical Industry

基　　金：广东省药品监督管理局2022年科技创新立项项目:中西药复方制剂质量风险评估创新团队(S2022TDB189)。

摘　　要：目的:建立高效液相色谱-蒸发光散射检测器(HPLC-ELSD)测定青蒿素哌喹片含量及溶出度方法,与二极管阵列检测器(DAD)测定结果进行比较。方法:色谱柱为InertsiLRODS-SP(4.6*150mm,5μm),流动相为0.2%甲酸溶液-乙腈,梯度洗脱,流速为0.7 mL/min,ELSD漂移管温度为50℃,气体流量为1.5 L/min,增益:1,柱温为40℃;溶出度评价方法为桨法;介质1为0.05 mol/L盐酸溶液,介质2为含0.5%SDS的磷酸盐缓冲液。结果:两种测定方法线性关系良好,均可进行含量测定,测定青蒿素溶出度时ELSD比DAD基线平稳,更为准确。结论:溶出度评价方法仍需进一步完善。Objective:To establish a method for the determination of artemisininin piperaquine content and dissolution by high performance liquid chromatography-evaporative light scattering detector(HPLC-ELSD),and to compare it with the determination results of diode array detector(DAD).Methods:The column was InertsiLR ODS-SP(4.6*150 mm,5μm),the mobile phase was 0.2%formic acid solution-acetonitrile,gradient eluted,the flow rate was 0.7 mL/min,the ELSD drift tube temperature was 50℃,the gas flow rate was 1.5 L/min,the gain:1,and the column temperature was 40℃.The dissolution evaluation method is paddle method;Media 1 is a 0.05 mol/L hydrochloric acid solution and Media 2 is a phosphate buffer containing 0.5%SDS.Results:The linear relationship between the two methods was good,and the content could be determined,and ELSD was stable and more accurate than DAD baseline when determining artemisinin dissolution.Conclusion:The dissolution evaluation method still needs to be further improved.

关 键 词：青蒿素哌喹片 HPCL-ELSD 含量测定 溶出度 

分 类 号：TQ[化学工程]