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
作者:尹晓莉;王江红;宋春丽;李琳丽;
Author:
收稿日期: 年卷(期)页码:2017,32(05):-549-551
期刊名称:华西药学杂志
Journal Name:WEST CHINA JOURNAL OF PHARMACEUTICAL SCIENCES
关键字:急性髓性白血病;YJ1026;FLT3;反相高效液相色谱法;专属性;精密度;含量测定;稳定性
Key words:
基金项目:国家自然科学基金资助项目(批准号:81473140)
中文摘要
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。
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