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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 establish an RP-HPLC method for the determination of cyclamen ester drug substance and its related substances. METHODS: The mobile phase was acetonitrile-water (4: 1) with a flow rate of 1.0 mL · min-1 and the detection wavelength was 228 nm using an Agilent Eclipse XDB-C18 column (4.6 mm × 250 mm, 5 μm) Results: The chromatogram peak of ring amylopectin was completely separated from the adjacent impurity peak. The linearity of cyclamen ester was in the range of 146.7 ~ 272.48μg.mL-1 (r = 0.9999). The RSD of precision test was 0.32% , The RSD of the repeatability test was 0.29%, and the RSD of the stability test was 0.62%. Conclusion: The method is simple, sensitive and accurate. It can be used for the determination of cyclamen ester and related substances.