期刊文献+

毛细管气相色谱法测定拉米夫定中有机溶剂的残留量 被引量:15

Determination of Residual Organic Solvents in Lamivudine by Capillary Gas Chromatography
原文传递
导出
摘要 目的:建立以毛细管气相色谱法测定拉米夫定中有机溶剂残留量的方法。方法:色谱柱为DB-624石英毛细管柱,柱温采用程序升温,载气为氮气,流速为40mL.min-1,进样口温度为230℃,检测器温度为250℃,分流比为20∶1。结果:有机溶剂甲醇、乙醇、乙酸乙酯、正己烷和吡啶的检测浓度的线性范围分别为60.0~420.0(r=0.9993)、100.0~700.0(r=0.9998)、100.0~700.0(r=0.9997)、5.8~40.6(r=0.9991)、4.0~28.0μg.mL-1(r=0.9999);平均回收率为98.4%~100.1%(RSD=2.0%~3.2%);最低检出限为0.26~0.88ng;3批样品中5种有机溶剂残留量均符合《中国药典》要求。结论:本方法简单、准确、灵敏度高、重现性好,可用于该制剂中有机溶剂残留量的测定。 OBJECTIVE: To develop capillary gas chromatography method for the determination of residual organic solvents in lamivudine. METHODS.. The residual organic solvents were separated on DB- 624 capillary column using temperature programming. The carrier was nitrogen gas, the flow rate was 40mL · min^ -1, the inlet temperature was 230℃, the detector temperature was 250℃ and the split ratio was 20 : 1. RESULTS. The linear ranges of methanol, ethanol, ethyl acetate, N - hexane and pyridine were 60.0~420.0( r = 0.999 3), 100.0~700.0 ( r = 0.999 8), 100.0~700.0( r = 0.999 7), 5.8~40.6( r = 0.999 1) and 4.0~28.0μg· mL^-1(r = 0.999 9), respectively. The average recoveries were ranged from 98.4% to 100.1% with RSD ranged at 2.0%~ 3.2%. The detection limits were 0.26~0.88ng. The residual levels for the five organic solvents in 3 batches of samples were all up to the standard stipulated in China Pharmacopeia . CONCLUSION : The method is simple, accurate, sensitive and reproducible, it can be used for the determination of the residual organic solvents in lamivudine.
出处 《中国药房》 CAS CSCD 北大核心 2007年第19期1502-1503,共2页 China Pharmacy
关键词 毛细管气相色谱法 拉米夫定 甲醇 乙醇 乙酸乙酯 正己烷 吡啶 残留量 Capillary gas chromatography Lamivudine Methanol Ethanol Ethyl acetate N - hexane Pyridine Residual volume
  • 相关文献

参考文献4

二级参考文献3

共引文献31

同被引文献44

引证文献15

二级引证文献49

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部