中文摘要：

目的：建立TM208含量及有关物质的RP-HPLC方法。方法：采用Phenomenex Luna C18（2）（150 mm×4.6 mm,5μm）色谱柱,流动相为水-甲醇（25∶75）,流速1.0 mL.min-1,检测波长254 nm,柱温25℃,进样量20μL。结果：TM208与其他物质分离良好,线性范围为1.0~200μg.mL-1（r=0.9997）,日内、日间精密度RSD均在5%以下,平均回收率为100.2%,检测限为50 ng.mL-1。结论：该方法快速、准确、灵敏。

英文摘要：

Objective：To establish RP-HPLC methods for the determination of TM208 and its related substances.Methods：Separation was performed on a Phenomenex Luna C18（2） column（150 mm×4.6 mm,5 μm）.The column temperature was maintained at 30 ℃,the detection wavelength was at 254 nm.The mobile phase consisted of water-methanol（25∶75） at the flow rate of 1.0 mL·min-1.The injection volume was 20 μL.Results：TM208 was separated completely from impurities.The linear range of TM208 was 1.0-200 μg·mL-1.The intra-and inter-day precision was lower than 5%.The average recovery of TM208 was 100.2%.The lowest limit of detection was 50 ng·mL-1.Conclusion：This method is fast,accurate and sensitive to determine TM208 and its related substances.