高效液相色谱法测定环扁桃酯原料有关物质及含量

RP-HPLC determination of content and related substances of cyclandelate

目的：建立反相高效液相色谱法测定环扁桃酯原料药的含量及其有关物质。方法：采用Agilent Eclipse XDB-C18（4.6mm×250 mm,5μm）色谱柱,流动相为乙腈-水（4∶1）,流速1.0 mL.min-1,检测波长228 nm。结果：环扁桃酯色谱峰与其相邻杂质峰能完全分离,环扁桃酯浓度在146.7~272.48μg.mL-1范围内呈良好的线性关系（r=0.9999）,精密度试验的RSD为0.32%,重复性试验的RSD为0.29%,稳定性试验的RSD为0.62%。结论：该方法简便、灵敏,结果准确,可用于环扁桃酯的含量及有关物质检查。

Objective：To develop an RP-HPLC method for determination of content and related substances of cyclandelate.Methods：Agilent Eclipse XDB-C18（4.6 mm×250 mm,5 μm） column was adopted,the mobile phase consisted of acetonitrile-water（4∶1） at a flow rate of 1.0 mL·min-1,the detection wavelength was 228 nm.Results：Good separation of cyclandelate and main related substances could be achieved.The standard curve was rectilinear in the range of 146.7-272.48 μg·mL-1（r=0.9999）.RSDs of the precision,the reproducibility and the stability test were 0.32%,0.29%,0.62%,respectively.Conclusion：The method is simple,accurate,reliable,and can be applied to the quality control of cyclandelate.