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Title:: Determination of Residual DL-Lactide,Glycolidc and 1,3-Trimethylene Carbonate in DL-Lactide-Glycolide-Trimethylene Carbonate Terpolymers

Author(s):: MA Lixia; ZHU Aichen; DONG Hao; LIU Yang; WANG Xianpeng; WANG Qin; WANG Chuandong; Shandong Academy of Pharmaceutical Sciences, Shandong Provincial Key Laboratory of Biomedical Polymers, Jinan 250101，China

Keywords:: Lactide; Glycolide; Trimethylene carbonate; Monomer residual; Gas chromatography

摘要:: 建立了聚乳酸-羟基乙酸-三亚甲基碳酸酯（PLGA-TMC）三元共聚物中丙交酯（DL-LA）、乙交酯（GA）、三亚甲基碳酸酯（TMC）三种单体残留测定的气相色谱法。采用GsBP-5毛细管色谱柱（30.0 m×0.32 mm, 0.25 μm），氢离子火焰检测器（FID），进样口温度250℃，检测器温度300℃，柱温135℃，分流比为10：1。结果显示，DL-LA、GA和TMC分离良好，精密度试验RSD值均不大于2.0%，三种单体在相应范围内线性关系良好，相关系数均在0.999以上，平均加样回收率均在97.17%～101.71%，且RSD值均不大于5.0%。该方法专属性强、准确度高，可用于PLGA-TMC三元共聚物中DL-LA、GA、TMC三种单体的定量检测，更好地控制PLGA-TMC的质量。

Abstract:: To establish a method of determination of residual DL-lactide (DL-LA), glycolide (GA) and 1,3-trimethylene carbonate (TMC) in DL-lactide-glycolide -trimethylene carbonate terpolymers (PLGA-TMC) by gas chromatography. GsBP-5 capillary column (30 m×0.32 mm, 0.25 μm), and FID detecter were used. The inlet temperature was set 250℃, the temperature of FID was 300℃, the column temperature was kept at 135℃, and the split ratio was 10:1. The results showed that DL-LA, GA and TMC were well separated, the relative standard deviations (RSDs) were all less than 2.0%, each monomer had a good linear relationship in the appropriate concentration range, and the correlation coefficient was not less than 0.999, the average recoveries were 97.17%～101.71%, and the RSDs were less than 5.0%.The method has good specificity and high accuracy, and can be used in the determination of residual monomers and the quality control of PLGA-TMC.