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HPLC法测定伊曲康唑片的含量及有关物质检查

Content Determination and Relative Substances Test of Itraconazole Tablets by HPLC

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【作者】 宋一赵玉香潘永泉

【Author】 Song Yi,Zhao Yuxiang and Pan Yongquan~1(Institute for Drug Control of Dalian City,Dalian,116021;~1The Second Hospital Affiliated to Dalian Medical University)

【机构】 辽宁省大连市药品检验所大连医科大学附属二院 116021116021

【摘要】 建立伊曲康唑片含量测定及有关物质检查的HPLC方法。色谱柱Kromasil C18;流动相:乙腈-磷酸盐缓冲液(65∶35);流速:1.2ml.min-1;检测波长:265nm;柱温:30℃;峰面积外标法。伊曲康唑在50~400μg.ml-1范围内有良好的线性关系,r=0.99996;平均回收率为98.81%,RSD=0.9%(n=9)。本法准确可靠,专属性强,能更好地控制其质量。

【Abstract】 A HPLC method was established for content determination and relative substances of Itraconazole tablets.A Kromasil C18 column was used with acetonitrile and phosphate buffer(65∶35) as mobile phase.The flaw rate was 1.2ml·min-1,column temperature was 30℃ and detecting wavelength was 265nm.The linear relationship was good when the content of itraconazole was 50400μg·m l-1(r=0.9996).The average recovery was 98.81% and RSD was 0.9%(n=9).The method was accurate,reliable and specific.It could be used for quality control of itraconazole tablets.

  • 【文献出处】 中国药事 ,Chinese Pharmaceutical Affairs , 编辑部邮箱 ,2006年03期
  • 【分类号】R927
  • 【被引频次】8
  • 【下载频次】243
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