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