HPLC 法测定聚（乳酸-乙醇酸）中的乳酸、乙醇酸含量

摘要

目的：建立用 HPLC 法测定聚（乳酸—乙醇酸）（PLGA）中的乳酸、乙醇酸的方法，以对该品的质量进行监测。方法色谱柱为十八烷基键合硅胶柱（4．6 mm ×250 mm，5μm），流动相为0．12％（v／v）磷酸溶液—乙腈（98∶2），检测波长为210 nm。供试样用三氯甲烷溶解后，用0．12％磷酸溶液萃取其中的乳酸和乙醇酸。结果供试样品中乳酸、乙醇酸与其它组分完全分离，检测限分别为0．09和0．10 mg·L －1，在0．5～2000 mg·L －1时，两酸的峰面积与浓度间线性关系良好（r ＝1．0000），低、中、高浓度的加标回收率为96％～101％，重复性和中间精密度的相对标准偏差均小于10％。结论该方法专属性、灵敏度、准确度与精密度均符合要求，适用于测定 PLGA 中的乳酸和乙醇酸。%Objective To establish an HPLC method for the determination of low concentration lactic acid and glycolic acid in poly (lactic-co-glycolic acid).Methods C18 column (4.6 mm ×250 mm,5 μm)was used.The mobile phase consisted of 0.12% phos-phoric acid solution-acetonitrile(98∶2)and the detective wavelength was set at 210 nm.Results Lactic acid and glycolic acid and im-purities in PLGA samples were separated completely.The calibration curves of both acids were linear within the range of 0.5 ~2 000 mg ·L -1 (r =1.000 0).The average recoveries of both acids were 96% ~101%.Both the repeatability and intermediate precision were good (RSD <10%).Conclusion The method is simple and accurate to determinate lactic acid and glycolic acid in PLGA.