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聚(DL-乳酸-羟基乙酸)共聚物75/25中有机溶剂残留量的GC测定

Determination of residual organic solvents in poly-(DL-lactide-co-glycolide) -75/25
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摘要 目的:测定聚(DL-乳酸-羟基乙酸)共聚物75/25中乙酸乙酯、二氯甲烷、乙醇的含量。方法:采用毛细管气相色谱法,色谱系统为:AC20色谱柱;柱温40℃;载气为氮气;检测器为FID;外标法计算含量。结果:在色谱条件下,测得各有机溶剂线性良好(r>0.99);平均回收率为99.3%~99.7%;RSD在0.15%~0.96%;最低检测限0.245~2.520μg·mL-1,3批样品中3种有机溶剂残留量符合要求。结论:该方法灵敏、准确、可靠。 Objective :To determine the concentrations of residual ethyl acetate, ethanol, methylene dichloride in poly-(DL-lactide-co-glycolide)-75/25 (PLCG). Methods:The quantification was con- ducted using a capillary gas chromatography consisted of a FID detector, the capillary column AC20 at 40 ℃ and nitrogen as a carrier gas. The residual solvent levels were monitored using an external standard method. Results:The concentrations of the three residual solvents showed appropriate linear curves (γ〉 0.99). The average recovery was 99.3 % -99.7 % and the RSD was 0.15% -0.96%. The detection limit was 0. 245 - 2. 520μg· mL^-1. Conclusion: The reliable and simple GC method to determine the residual organic solvents was attainable.
出处 《中国新药杂志》 CAS CSCD 北大核心 2006年第6期461-463,共3页 Chinese Journal of New Drugs
关键词 毛细管气相色谱法 聚(DL-乳酸-羟基乙酸)共聚物 残留有机溶剂 capillary gas chromatography poly (DL-lactide-co-glycolide) residual organic solvent
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  • 1European Pharmacopoeia Commission. European Pharmacopoeia Supplement[ S]. Strasbourg: European Department for the Quality of Medicines within the Council of European. 1999:205 -214.
  • 2姜红,李正群,左阿玲,熊伟,张春瑛,程樱.舒巴坦匹酯原料残留溶剂的评价[J].中国药师,2002,5(2):73-74. 被引量:4

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