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气固顶空色谱法测定植入用缓释氟尿嘧啶中环己烷

Head-space gas chromatographic determination of residual solvent in fluorouracil sustained-release subcutaneous implant

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【作者】 王世亮; 储成顶; 周浩炳; 张海燕; 谢正; 叶红杨;

【Author】 WANG Shi-liang ,CHU Cheng-ding, ZHOU Hao-bin, ZHANG Hai-yan ,XIE Zheng, YE Hong-yang( The Sustained-Release Drug Laboratory , Hefei University of Technology ,Hefei 230009, China ; Center of Physics and Chemistry , Anhui Medical University,Hefei 230032 , China ; Anhui Professional and Technical College , Hefei 230051, China )

【机构】 合肥工业大学控释药物研究室; 安徽医科大学理化中心; 合肥工业大学控释药物研究室 合肥 230009 3 安徽职业技术学院; 合肥 230051; 合肥 230009 2 安徽医科大学理化中心; 合肥 230032; 合肥 230009; 合肥 230009;

【摘要】 目的:测定植入用缓释氟尿嘧啶中环已烧残留量。方法:研碎供试品,置针管中于60℃保温作气固顶空平衡,顶空气以气相色谱法测定,氢焰检测器,SE-30固定相,柱温80℃。结果:方法的精密度RSD为2.8%,回收率为101.4%,10~110ng·mL-1范围内线性良好,检出限为3.4ng·mL-1。结论:为类似难溶性固体药物的有机溶剂残留量检测提供了可靠的方法。

【Abstract】 Objective: To determine cyclohexane, a residual solvent, in fuorouracil sustained-release subcutaneous implant. Methods: Pulverized sample was put into a syringe and maintained at 60^ for balance. The cyclohexane was determined with GC using SE-30 as stationary phase, a column temperature of 80℃, and a hydrogen flame detector. Results: The liner range of cyclohexane was 10-110ng·mL-1( r = 0. 999 8,n =6) with a detection limit of 3. 4ng·mL-1. The average recovery was 101.4% with a RSD of 2. 8 % . Conclusion: A reliable method was provided by the authors for determination of residual solvent in sparingly soluble drugs similar to fluorouracil.

  • 【文献出处】 中国新药杂志 ,Chinese New Drugs Journal , 编辑部邮箱 ,2003年12期
  • 【分类号】R927
  • 【被引频次】7
  • 【下载频次】81
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