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高效液相色谱法测定泛酸钠中的有关物质

Determination of the related substances in D-sodium pantothenate by HPLC

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【作者】 黎玲王东凯王丽君杨秀丽薛梅妍庄润

【Author】 LI Ling~1 WANG Dong-kai~1 WANG Li-jun~1 YANG Xiu-li~1 XUE Mei-yan~1 ZHUANG Run~2 (1 School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;2 Watson Pharmaceutical Institute of Shenyang,Shenyang 110016,China)

【机构】 沈阳药科大学药学院沈阳沃森药物研究所 沈阳110016沈阳110016

【摘要】 目的:建立高效液相色谱法检测泛酸钠原料中的有关物质。方法:氨基硅烷键合相色谱柱(300 mm×4.6 mm,5μm);流动相:0.05 mol·L-1磷酸二氢钾溶液-乙腈(30:70),用10%磷酸溶液调节pH为5.8;检测波长: 214 nm;流速:1.5 mL·min-1。结果:杂质峰与主峰能够得到有效的分离,最低检出浓度为10 ng·mL-1,3批泛酸钠样品经检测有关物质分别为0.10%,0.08%,0.12%。结论:该法可用于检查泛酸钠原料中的有关物质,简便、准确。

【Abstract】 Objective:To establish a HPLC method for determination of the related substances in D-sodium pantothenate.Methods:The HPLC condition was as follows:a NH2 column(300mm×4.6mm,5μm),the mobile phase consisted of 0.05 mol.L-1 monobasic potassium phosphate solution-acetonitrile (30:70)(pH 5.8,adjusted with 10% phosphoric acid) with a flow rate of 1.5 mL·min-1 and the UV detection at 214 nm.Results:The major components could be satisfactorily separated from the related substances.The detection limit was 10 ng·mL-1.The impurity rate of three batches of D-sodium pantothenate samples was 0.10%,0.08% and 0.12%,respectively.Conclusion:The simple and accurate HPLC method could be used in the quality control of D-Sodium pantothenate.

  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2006年03期
  • 【分类号】R927
  • 【被引频次】1
  • 【下载频次】104
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