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RP-HPLC法同时测定苯甲酸原料药中有关物质苯甲醛和甲苯的含量

章家伟 王辉 孙庆荣 王向峰 雷玉萍 帅放文

中国药房2013,Vol.24Issue(29):2754-2757,4.
中国药房2013,Vol.24Issue(29):2754-2757,4.DOI:10.6039/j.issn.1001-0408.2013.29.24

RP-HPLC法同时测定苯甲酸原料药中有关物质苯甲醛和甲苯的含量

Simultaneous Determination of Related Substances Benzaldehyde and Toluene in Benzoic Acid Crude Drug by RP-HPLC

章家伟 1王辉 2孙庆荣 1王向峰 2雷玉萍 1帅放文2

作者信息

  • 1. 湖南尔康制药股份有限公司,长沙410331
  • 2. 湖南省药用辅料工程技术研究中心,长沙410331
  • 折叠

摘要

Abstract

OBJECTIVE:To establish a method for the determination of related substances benzaldehyde and toluene in benzoic acid crude drug.METHODS:RP-HPLC method was adopted.The determination was performed on WondasilTM-C18 column with mobile phase consisted of methanol-0.02 mol/L ammonium acetate (pH 4.0) (80 ∶ 20) at the flow rate of 0.5 ml/min.The detection wavelength was set at 254 nm.RESULTS:Benzoic acid,benzaldehyde and toluene could be separated completely.The linear range of benzaldehyde and toluene were 2.0-7.2 μg/ml (r=0.999 5) and 1.75-6.30 μg/ml (r=0.998 9) respectively.The detection limits were 0.05 μg/ml and 0.2 μg/ml.The average recoveries were 100.57% (RSD=0.99%,n=9) and 99.58% (RSD=0.86%,n=9),respectively.CONCLUSIONS:This method is sensitive and accurate,and it can be used for the simultaneous determination of related substances benzaldehyde and toluene in benzoic acid crude drug.

关键词

反相高效液相色谱法/苯甲酸/苯甲醛/甲苯/有关物质/含量测定/限度

Key words

RP-HPLC/Benzoic acid/Benzaldehyde/Toluene/Related substances/Content determination/Limit

分类

医药卫生

引用本文复制引用

章家伟,王辉,孙庆荣,王向峰,雷玉萍,帅放文..RP-HPLC法同时测定苯甲酸原料药中有关物质苯甲醛和甲苯的含量[J].中国药房,2013,24(29):2754-2757,4.

中国药房

OACSCDCSTPCD

1001-0408

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