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作者:

Han, Zunsheng (Han, Zunsheng.) | Lu, Liping (Lu, Liping.) (学者:鲁理平) | Wang, Lin (Wang, Lin.) | Yan, Zimeng (Yan, Zimeng.) | Wang, Xiayan (Wang, Xiayan.) (学者:汪夏燕)

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Scopus SCIE

摘要:

A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for determination of ibuprofen and 17 related compounds (chemical process impurities and degradation products) simultaneously. This method may be used for quality control of ibuprofen-containing substances. A number of chromatographic parameters (column, flow rate, temperature, wavelength, gradient elution, buffer solution, and pH) were evaluated. An Agilent ZORBAX Eclipse Plus C18 (250 x 4.6 mm, 5 mu m particle size) column at 40 A degrees C was selected on the basis of its separation efficiency and robustness. The column was eluted at 1.0 mL min(-1) with a gradient using 10 mM sodium phosphate buffer at pH 6.9 as mobile phase A and acetonitrile as mobile phase B. The ultraviolet detector was set at 214 nm. This method was validated to confirm its system suitability, specificity, linearity, precision, accuracy, sensitivity, robustness, and sample stability according to international conference on harmonization (ICH) guidelines. This method was applied to analyze seven batches of ibuprofen drug products from different manufacturers.

关键词:

Related compounds Method development and validation Ibuprofen HPLC

作者机构:

  • [ 1 ] [Han, Zunsheng]Beijing Univ Technol, Coll Environm & Energy Engn, Beijing, Peoples R China
  • [ 2 ] [Lu, Liping]Beijing Univ Technol, Coll Environm & Energy Engn, Beijing, Peoples R China
  • [ 3 ] [Wang, Lin]Beijing Univ Technol, Coll Environm & Energy Engn, Beijing, Peoples R China
  • [ 4 ] [Wang, Xiayan]Beijing Univ Technol, Coll Environm & Energy Engn, Beijing, Peoples R China
  • [ 5 ] [Yan, Zimeng]Qilu Pharmaceut Hai Nan Co Ltd, Haikou, Hainan, Peoples R China

通讯作者信息:

  • 汪夏燕

    [Wang, Xiayan]Beijing Univ Technol, Coll Environm & Energy Engn, Beijing, Peoples R China;;[Yan, Zimeng]Qilu Pharmaceut Hai Nan Co Ltd, Haikou, Hainan, Peoples R China

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来源 :

CHROMATOGRAPHIA

ISSN: 0009-5893

年份: 2017

期: 9

卷: 80

页码: 1353-1360

1 . 7 0 0

JCR@2022

ESI学科: CHEMISTRY;

ESI高被引阀值:212

中科院分区:4

被引次数:

WoS核心集被引频次: 23

SCOPUS被引频次: 22

ESI高被引论文在榜: 0 展开所有

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