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目的采用HPLC法测定新型抗黑色素瘤小分子药物Y731原料药的含量,并考察其稳定性。方法采用Phenomenex-C_(18)柱(150 mm×4.6 mm,5μm),流动相为10 mmol·L~(-1)乙酸铵(p H9.2)-乙腈(50∶50),检测波长272 nm,流速1.0 m L·min~(-1),柱温30℃。结果 Y731能与相邻杂质峰完全分离,其线性范围为5~160μg·m L~(-1)(r=0.9995);高、中、低浓度样品的平均加样回收率分别为100.77%、100.52%、101.26%,RSD分别为1.56%、1.00%、1.45%(n=3);Y731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Y731的含量测定和稳定性研究。
Objective To determine the content of novel anti-melanoma Y731 drug substance by HPLC and investigate its stability. Methods A Phenomenex-C 18 column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of 10 mmol·L -1 ammonium acetate (p H9.2) -acetonitrile (50:50) nm, the flow rate was 1.0 m L · min ~ (-1) and the column temperature was 30 ℃. Results The linear range of Y731 was 5 ~ 160μg · m L -1 (r = 0.9995). The average recoveries of high, medium and low concentration samples were 100.77% 100.52% and 101.26%, RSD 1.56%, 1.00% and 1.45% respectively (n = 3). Y731 was stable under high temperature, high humidity and strong light irradiation. Conclusion The method used is specific and sensitive, suitable for the determination of Y731 content and stability.