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高效液相色谱法测定注射用兰索拉唑中兰索拉唑的含量

Determination of related substances in lansoprazole for injection by high performance liquid chromatography

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【作者】 许萌鹿梦溪周春华徐德华张雪宁宋娟

【Author】 XU Meng;LU Meng-xi;ZHOU Chun-hua;XU De-hua;ZHANG Xue-ning;SONG Juan;Department of Pharmacy,the Second Hospital of Hebei Medical University;College of Basic Medical,North China University of Science and Technology;Department of Pharmacy,Hebei Medical University;

【机构】 河北医科大学第二医院药学部华北理工大学基础医学院河北医科大学药学院药物分析教研室

【摘要】 目的采用高效液相色谱法建立测定兰索拉唑及其制剂注射用兰索拉唑含量的方法。方法色谱柱为Diamonsil C18(4.6mm×250mm,5μm);流动相为甲醇∶水(70∶30);检测波长为285nm;流速1.0mL/min;柱温25℃;进样量20μL。结果注射用兰索拉唑制剂中的辅料对兰索拉唑的测定无干扰,兰索拉唑在50~500mg/L浓度范围内与峰面积呈良好的线性关系,精密度[相对标准差(relative standard deviation,RSD)=0.14%]良好;低、中、高3种浓度平均回收率分别为100.0%、98.3%、101.7%,RSD分别为0.5%、0.3%、0.4%。结论该方法简便、准确、专属性好,可用于兰索拉唑及其制剂含量的测定。

【Abstract】 Objective To use high performance liquid chromatography for the determination of the content of lansoprazole and lansoprazole injection. Methods The determination was carried out on with a Dikma Diamonsil TM2C18(4.6mm×250mm,5μm)column.The mobile phase was methanol-water(70∶30).The determination wavelength was 285 nm.Results The excipients did not interfere with the determination of lansoprazole.The developed method could be used for the determination of lansoprazole and its injection.The calibration curve of lansoprazole was in good linearity over the range of 50-500mg/L.The precision of the method(relative standard deviation[RSD]=0.14%)was good.The average recovery of the low,medium,and high concentrations were 100.0%,98.3%,101.7% with RSD 0.5%,0.3%,0.4%respectively.Conclusion The method is simple,accurate and specific.It can be used for the determination of lansoprazole.

【基金】 河北省医学科学研究重点课题(20150677;20150261);河北省药学会临床药学专项科研项目计划(YX201501)
  • 【文献出处】 河北医科大学学报 ,Journal of Hebei Medical University , 编辑部邮箱 ,2016年01期
  • 【分类号】R927.2;O657.72
  • 【被引频次】2
  • 【下载频次】127
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