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目的采用RP-HPLC法测定新型抗非小细胞肺癌小分子药物YL725的含量,并考察其稳定性。方法采用Venusil XBP-C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(60∶40),检测波长273 nm,流速1.0 m L·min~(-1),柱温30℃。结果在选定的色谱条件下,YL725能与相邻杂质完全分离;4~120μg·m L~(-1)YL725与峰面积的线性关系良好(r=0.9999);高、中、低浓度精密度试验的RSD分别为0.75%、0.81%、0.70%(n=5);平均加样回收率及RSD分别为99.76%、99.58%、100.14%和1.98%、0.36%、0.32%(n=3);重复性试验的RSD=1.15%(n=5);YL725在高温、高湿和强光照射条件下稳定。结论所用方法专属性强、灵敏度高,适用于YL725的含量测定和稳定性研究。
Objective To determine the content of a novel small molecule anti-non-small cell lung cancer drug YL725 by RP-HPLC and investigate its stability. Methods Venusil XBP-C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile and water (60:40). The detection wavelength was 273 nm and the flow rate was 1.0 m L · min -1. Column temperature 30 ℃. Results Under the selected chromatographic conditions, YL725 was completely separated from the adjacent impurities. The linear relationship of YL725 with 4 ~ 120μg · m L -1 was good (r = 0.9999) The average RSDs of RSD were 99.76%, 99.58%, 100.14% and 1.98%, 0.36% and 0.32%, respectively (n = 3 ); RSD of repeatability test = 1.15% (n = 5); YL725 is stable under high temperature, high humidity and strong light irradiation. Conclusion The method used is specific and sensitive, suitable for the determination of YL725 content and stability.