气相色谱法测定药用辅料聚乳酸中丙交酯残留量

Determination of Residual Lactide in the Excipient Poly (lactic acid) by GC

目的建立聚乳酸中丙交酯残留量的测定方法。方法采用毛细管气相色谱法,色谱柱为Agilent HP-5(30.0m×0.32mm,0.25μm),柱温150℃;分流比10∶1;检测器为氢火焰离子化检测器(FID),检测器温度为250℃,进样口温度为200℃。结果丙交酯在90.1~675.9μg·mL^-1范围内与峰面积线性关系良好(r=0.9999),平均回收率为96.5%,RSD为3.3%(n=9),定量限为2.9μg·mL^-1。结论该方法专属性强,重复性好,灵敏度高,结果可靠,适用于聚乳酸中丙交酯的残留检查。

OBJECTIVE To establish a method to determine the residual solvent lactide in poly(lactic acid).METHODS The GC was carried out with Agilent HP-5 capillary column(30.0m×0.32mm,0.25μm).The column temperature was 150℃,Split ratio was 10∶1,the temperature of FID detector was 250℃,The inlet temperature was 200℃.RESULTS The standard curves of lactide was linear within the ranges of 90.1-675.9μg·mL^-1(r=0.9999).The average recovery of lactide was 96.5%,the RSD for replications were 3.3%(n=9).The limit of quantitation was 2.9μg·mL^-1.CONCLUSION The method is specific,reproducible,high sensitive and reliable,which can be used todetermine the lactide residue in poly(lactic acid).