文章摘要
朱平,李娜,王志敏.效液相色谱法测定奥扎格雷钠注射液中有关物质[J].山西医科大学学报,2007,38(11):1010~1012
效液相色谱法测定奥扎格雷钠注射液中有关物质
Determination of related substances in ozagrel sodium injection by HPLC
  
DOI:
中文关键词: 色谱法,高压液相  奥扎格雷钠  有关物质
英文关键词: chromatography,high pressure liquid  ozagrel sodium  related substances
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作者单位
朱平,李娜,王志敏 山西华元医药集团太原030032 
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中文摘要:
      目的 建立高效液相色谱法测定奥扎格雷钠注射液中有关物质的方法。 方法选用C18柱;以0.01 mol/L磷酸二氢钾溶液-甲醇(75∶25)(用氢氧化钠 溶液调 节 pH 6.0)为流动相;波长:272 nm;流速:1.0 ml/min;进样量:20 μl;柱温:25 ℃ 。 结果 空白辅料无干扰,降解产物与主成分峰都能完全分离;检测限 约 为0.3 ng,定量限约为1.0 ng。 结论 该测定方法简便、快速、可靠, 可用于奥扎格雷钠注射液中有关物质的测定。
英文摘要:
      Objective To establish a high perfo rmance liquid chromatography (HPLC) method for determining related substances in ozagrel sodium injection. Methods The related substances were determined by HPLC. The HPLC system consisted of C18 column, 0.01 mol/ L potassium dihydrogen phosphate buffer methanol (7 5∶25)( adjusted to pH 6.0 with sodium hydroxide solution) as the mobile phase, the colu mn temperature at 25 ℃, the flow rate of mobile phase 1.0 ml/ min, the waveleng th of detector at 272 nm and the injection volume 20 μl. Results Additives did no t interfere with the quantitation of related substances in ozagrel sodium inject ion, and the principal peak was thoroughly separated with the degradation produ ct pe ak. The detection limit was about 0.3 ng, and the quantitation limit was ab out 1.0 ng. Conclusion The method is simple, rapid and suitable. It can be used to dete rmine related substances in ozagrel sodium injection.
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