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HPLC测定精氨酸布洛芬注射液的含量及有关物质 被引量:1

Determination of ibuprofen and related substances in Ibuprofen arginine injection by HPLC
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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.
出处 《华西药学杂志》 CAS CSCD 北大核心 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)
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 Ibuprofen arginine injection RP - HPLC Content Related substance
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