中文摘要：

目的采用HPLC法测定新型抗急性髓性白血病小分子药物SKLB-1103的含量,并考察其稳定性。方法采用Wa-ters XTerra C18柱（150 mm×4.6 mm,5μm）,用二元梯度洗脱方式,流动相A为乙腈,流动相B为醋酸铵溶液（20 mmol.L-1,氨水调pH9.5）,检测波长为288 nm,柱温35℃,流速1.0 mL.min-1。结果 SKLB-1103的峰能与相邻杂质峰完全分离。1～100μg·mL-1SKLB-1103与峰面积的的线性关系良好（r=0.9999）,平均回收率为98.36%,RSD=1.6%;重复性试验的RSD=1.1%;高、中、低浓度的精密度试验的RSD分别为0.22%、0.64%、0.14%。SKLB-1103在高温和高湿条件下稳定,但对光不稳定。结论所用方法快速简便、灵敏度和准确度较高,可作为SKLB-1103的稳定性及降解动力学研究的含量测定方法。

英文摘要：

OBJECTIVE To establish a content determination method of a novel targeted drug SKLB-1103 for treating acute myeloid leukemia and to investigate its stability.METHODS In the method,Waters XTerra C18 column was used.The mobile phase A was acetonitrile and the mobile phase B was water containing 20 mmol·L-1 ammonium acetate（adjusted pH to 9.5 with ammonia）.The UV detection wavelength was 288 nm,the column temperature was 35 ℃ and the flow rate was 1.0 mL·min-1.RESULTS SKLB-1103 could be effectively separated with impurities.The calibration curve was linear in the range of 1-100 μg·mL-1（r=0.9999）.The average recovery was 98.36%（RSD=1.6%）.The reproducibility was 1.1%,and the precisions at different concentrations were 0.22%,0.64% and 0.14%,respectively.SKLB-1103 was stable to both moisture and heat,but unstable to light.CONCLUSION The method is selective,simple and accurate.It is applicable for the analysis of SKLB-1103 in the presence of its degradants.