HPLC 法测定聚（乳酸-乙醇酸）中的乳酸、乙醇酸含量

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。

Determination of lactic acid and glycolic acid in PLGA by HPLC

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.