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高效液相色谱法测定磺丁基-β-环糊精中的β-环糊精残留含量

HPLC determination of β-cyclodenxtin in sufobutylether-β-cyclodenxtin

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【作者】 于嘉鑫刘子列任勇王猛

【Author】 YU Jia-xin1,LIU Zi-lie1,REN Yong1*,WANG Meng2(1.New Drugs Research Center,Nanjing Normal University,Nanjing 210097,China; 2.Nanjing J.one Medical Technology Development Co.,Ltd.,Nanjing 210097,China)

【机构】 南京师范大学新药研究中心南京巨环医药科技有限公司

【摘要】 目的:建立磺丁基-β-环糊精中有关物质β-环糊精检测及含量测定的高效液相色谱分析。方法:采用Waters XTerraMs-C18(4.6 mm×250 mm,5μm)柱;流动相:甲醇-水(8∶92);检测器:示差折光率检测器;流速:0.8 mL·min-1;柱温:25℃。结果:在所选定的色谱条件下,磺丁基-β-环糊精与β-环糊精能分离完全;β-环糊精在0.1~1.6 mg·mL-1内,峰面积与浓度线性关系良好,r=0.9999;最低检测限为2μg。结论:方法简便,准确,专属性强,可用于磺丁基-β-环糊精中的β-环糊精检测及含量测定质量控制。

【Abstract】 Objective:To develop a HPLC method for the determination of sufobutylether-β-cyclodenxtin and β-cyclodenxtin for quality control.Methods:The separation was carried out on a Waters XTerra Ms-C18 column(4.6 mm×250 mm,5 μm),using a mixture of methanol-water(8∶92)as the mobile phase at a flow rate of 0.8 mL·min-1.The Refractive Index Detection,the column temperature was 25 ℃.Results:Under the established chromatographic conditions,sufobutylether-β-cyclodenxtin and β-cyclodenxtin were separated completely.The standard curve was linear within the range of 0.0625-1.5 mg·L-1 with the correlation coefficient of 0.9999,the limit of detection was 0.1 mg.Conclusion:The established method is simple,accurate,specific and can be used for quality control of sufobutylether-β-cyclodenxtin.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2011年04期
  • 【分类号】R917
  • 【被引频次】3
  • 【下载频次】525
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