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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。
Objective To determine the content of a novel anti-acute myeloid leukemia SKLB-1103 by HPLC and investigate its stability. Methods The mobile phase A was acetonitrile and the mobile phase B was ammonium acetate solution (20 mmol·L-1, ammonia water, pH9) using a Wa-ters XTerra C18 column (150 mm × 4.6 mm, 5 μm) .5). The detection wavelength was 288 nm, the column temperature was 35 ℃ and the flow rate was 1.0 mL.min-1. As a result, the peak energy of SKLB-1103 was completely separated from the adjacent impurity peak. The linear relationship between peak area and concentration of 1 ~ 100μg · mL-1SKLB-1103 was good (r = 0.9999), the average recovery was 98.36%, RSD was 1.6%; RSD of repeatability test was 1.1% The RSD of precision test were 0.22%, 0.64% and 0.14% respectively. SKLB-1103 is stable under high temperature and high humidity, but unstable to light. Conclusion The method is rapid, simple, sensitive and accurate. It can be used as a method for determination of the stability and degradation kinetics of SKLB-1103.