高效液相色谱法测定环扁桃酯原料有关物质及含量

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(4.6 mm×250 mm,5 μm)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146.7~272.48 μg·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.