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[1]付修志,毛黎顺,孙玲,等.注射用兰索拉唑中葡甲胺含量的测定方法[J].南京工业大学学报(自然科学版),2015,37(06):131-134.[doi:10.3969/j.issn.1671-7627.2015.06.024]
 FU Xiuzhi,MAO Lishun,SUN Ling,et al.Determination of melamine content in lansoprazole[J].Journal of NANJING TECH UNIVERSITY(NATURAL SCIENCE EDITION),2015,37(06):131-134.[doi:10.3969/j.issn.1671-7627.2015.06.024]
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注射用兰索拉唑中葡甲胺含量的测定方法()
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《南京工业大学学报(自然科学版)》[ISSN:1671-7627/CN:32-1670/N]

卷:
37
期数:
2015年06期
页码:
131-134
栏目:
出版日期:
2015-11-20

文章信息/Info

Title:
Determination of melamine content in lansoprazole
文章编号:
1671-7627(2015)06-0131-04
作者:
付修志1毛黎顺2孙玲1何学军1王莉佳1
1.南京工业大学 药学院,江苏 南京 210009; 2.南京柯菲平制药有限公司,江苏 南京 210009
Author(s):
FU Xiuzhi1MAO Lishun2SUN Ling1 HE Xuejun1 WANG Lijia1
1.College of Pharmaceutical Sciences,Nanjing Tech University,Nanjing 210009,China; 2.Nanjing Carefree Pharmaceutical Co. Ltd.,Nanjing 210009,China
关键词:
兰索拉唑 葡甲胺 高效液相色谱仪 含量测定
Keywords:
lansoprazole meglumine HPLC content determination
分类号:
R917
DOI:
10.3969/j.issn.1671-7627.2015.06.024
文献标志码:
A
摘要:
建立视差折光检测器-高效液相色谱仪(HPLC)联用方法,测定注射用兰索拉唑中葡甲胺的含量。高效液相色谱仪采用氢型阳离子交换树脂和磺化交联的苯乙烯-二乙烯基共聚物为填充剂的硅胶基质色谱柱(SHISEIDO CAPCELL PAK 150 mm×4.6 mm,5 μm),柱温35 ℃,以三氟乙酸-甲酸-水(体积比为0.05:0.3:100,流速为0.6 mL/min)为流动相。结果表明:在0.169 0~3.380 0 g/L的范围内,葡甲胺的浓度与峰面积呈良好线性关系,相关系数为0.999 9。平均回收率(n=3)为99.80%,相对标准偏差(RSD)为0.5%。
Abstract:
To develop a quantitative method with differential refraction-high performance liquid chromatograph(HPLC)for determining the contents of meglumine in lansoprazole. The analysis was performed with a irregular or spherical totally porous silica gel with chemically bonded strongly acidic ation-exchange(SHISEIDO CAPCELL PAK 150 mm×4.6 mm,5 μm). The mobile phase was trifluoroacetic acid(TFA)-formic acid-water(0.05:0.3:100)and its flow rate was 0.6 mL/min,differential refractive index detector. The column temperature was 35 ℃. The calibration curve was linear with the range of 0.169 0-3.380 0 mg/mL for meglumine(R2=0.999 9). The average recovery rate of the two contents was 99.80% and the RSD was 0.5%.

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备注/Memo

备注/Memo:
收稿日期:2014-05-08
作者简介:付修志(1988—),男,湖北枣阳人,硕士,主要研究方向为药物分析; 何学军(联系人),副教授, E-mail:hxj@njtech.edu.cn.
引用本文:付修志,毛黎顺,孙玲,等.注射用兰索拉唑中葡甲胺含量的测定方法[J].南京工业大学学报:自然科学版,2015,37(6):131-134..
更新日期/Last Update: 2015-11-20