HPLC测定精氨酸布洛芬注射液的含量及有关物质  

Determination of ibuprofen and related substances in Ibuprofen arginine injection by HPLC

作　　者：彭东明[1] 王福东[1] 卢茂芳[1] 刘艳飞[2] 

机构地区：[1]湖南中医药大学药学院,湖南长沙410208 [2]中南大学化学化工学院,湖南长沙410083

出　　处：《华西药学杂志》2013年第2期195-196,共2页West China Journal of Pharmaceutical Sciences

基　　金：湖南省教育厅资助项目(编号:11C0951);湖南省科技计划项目(编号:2012SK3134)

摘　　要：目的采用HPLC法测定精氨酸布洛芬注射液的含量及有关物质。方法采用Waters C18色谱柱(150 mm×3.9 mm,5μm),流动相为水(磷酸调pH2.5)-乙腈(67∶34),检测波长214 nm,流速2.0 mL.min-1。结果布洛芬0.1～0.8 mg.mL-1与峰面积呈良好的线性关系(r=0.9986);最低检测限为28.2 ng;方法精密度RSD=0.63%(n=6);平均回收率为99.9%(n=9)。结论所用方法准确、灵敏、简便、快速,可用于精氨酸布洛芬注射液的含量及有关物质的测定。OBJECTIVE To establish a method for determination of ibuprofen content and related substances in Ibuprofen arginine injection. METHODS Waters C18 column（ 150 mm×3.9 ram,5 μm） was used with mobile phase consisting of water （adjusted to pH2.5 with phosphoric acid） ：acetonitrile （67：34）. The detective wavelength was set at 214 rim, and the flow rate was 2.0 mL·min^-1. RESULTS The linear range of ibuprofen was within 0.1 - 0.8 mg·mL- 1 （r = 0.9986 ）. The lowest examination limits was 28.2 ng. The RSD was 0.63% （ n = 6） , and the average recovery rate was 99.9% （ n = 9）. CONCLUSION The method is accurate, sensitive and simple. It can be used for determination of ibuprofen content and related substances in Ibuprofen arginine injection.

关 键 词：精氨酸布洛芬注射液 高效液相色谱法 含量 有关物质 

分 类 号：R917[医药卫生—药物分析学]