抗急性髓性白血病新型药物YJ1026的含量测定及稳定性研究

Determination and stability study of a novel anti-acute myeloid leukemia drug YJ1026

目的采用RP-HPLC测定新型抗急性髓性白血病药物YJ1026的含量,并考察其稳定性。方法采用PhenomenexC^(18)色谱柱(150 mm×4.6 mm,5μm),流动相为乙腈-水(45∶55),检测波长309 nm,流速1.0 m L·min^(-1),柱温30℃。结果在选定的色谱条件下,YJ1026能与相邻杂质完全分离,4~80μg·m L^(-1)YJ1026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1.23%、1.91%、1.96%,平均加样回收率分别为98.92%、99.35%、100.5%,RSD分别为0.69%、0.38%、1.35%,重复性试验的RSD=1.52%;YJ1026在高温、高湿和强光照射条件下稳定。结论所用方法简便、快速、专属性强、灵敏度高,适用于YJ1026的含量测定和稳定性研究。

OBJECTIVE To establish a RP-HPLC method for the determination of a novel anti-acute myeloid leukemia drug YJ1026,and to investigate its stability. METHODS Phenomenex-C（18） 150 mm × 4. 6 mm,5 μm） column was used. The mobile phase was acetonitrile-water（ 45∶55） with the flow rate of 1. 0 m L·min^（-1）. The UV detection wavelength was 309 nm and the column temperature was 30 ℃. RESULTS Under the selected chromatographic conditions,YJ1026 could be effectively separated from impurities. The calibration curve was linear in the range of 4-80 μg·m L^（-1）（ r = 0. 9999）. The precision of the method at different concentrations were 1. 23%,1. 91% and 1. 96%,respectively. The average recovery and RSD were 98. 92%,99. 35%,100. 5% and 0. 69%,0. 38%,1. 35%,respectively. The reproducibility was 1. 52%. The result of influencing factors showed that YJ1026 was stable under the conditions of heat,moisture and light. CONCLUSION The method is simple,selective and accurate. It can be applied to analyze the content of YJ1026 and investigate its stability.