目的： 建立抗肺癌新型化合物 TPX-0005有关物质检测的高效液相色谱法,为 TPX-0005的质量控制提供实验依据。方法： 采用Agilent HC-C18（4.6 mm×150 mm,5 μm）色谱柱,流动相 0.1% 甲酸水溶液（A）-乙腈（B）,梯度洗脱（0~2 min,30%B;2~30 min,30%B → 50%B;30~35 min,50%B→ 70%B;35~36 min,70%B → 30%B;36~45 min,30%B）,检测波长230 nm,柱温35 ℃,流速1.0 mL·min-1。结果： TPX-0005 主峰与其相邻杂质峰之间的分离度大于1.5,其他杂质峰之间的分离度大于1.4;质量浓度在 0.1~20.2 μg·mL-1 范围内,与峰面积呈现良好的线性关系（r=0.999 2）;检测下限、定量下限分别为 0.03、0.08 μg·mL-1。结论： 该方法适合 TPX-0005的有关物质的测定,可为TPX-0005的后续研究与开发提供有价值的参考。
Objective： To establish an HPLC method for the analysis of related substances in TPX-0005,a new anti-lung cancer compound,and to provide experimental basis for the quality control of TPX-0005. Methods： The Agilent HC-C18 column（4.6 mm×150 mm,5 μm）was used as the chromatographic column with the mobile phase consisting of 0.1% formic acid-water solution（A）and acetonitrile（B）in gradient elution model. The gradient elution procedure was as follows：0-2 min,30%B;2-30 min,30%B → 50%B;30-35 min,50%B → 70%B;35-36 min,70%B → 30%B;36-45 min,30%B. The detection wavelength was 230 nm,the column temperature was 35 ℃ and the flow rate was 1.0 mL·min-1. Results： The resolution between the main peak of TPX-0005 and its adjacent impurity peaks was greater than 1.5,and that of other impurities was greater than 1.4. There was a good linear relationship between the concentration and the peak area in the range of 0.1-2.2 μg·mL-1（r=0.999 2）. The concentration of detection limit and quantitative limit were 0.03 μg·mL-1 and 0.08 μg·mL-1 respectively. Conclusion： The method is suitable for the determination of related substances in TPX-0005,and can provide valuable reference for the follow-up research and development of TPX-0005.
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