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目的采用RP-HPLC法测定抗银屑病新型小分子药物Y263的含量,并考察其稳定性。方法采用Kromasil-C18色谱柱(150 mm×4.6 mm,5μm),流动相为乙腈-水(50∶50),检测波长249 nm,流速1.0 m L·min-1,柱温30℃。结果在选定的色谱条件下,Y263能与相邻杂质峰完全分离,4~80μg·m L-1Y263与峰面积的线性关系良好(r=0.9999);高、中、低浓度的RSD分别为0.80%、0.57%、1.53%,平均回收率和RSD分别为101.58%、100.52%、99.26%和1.12%、0.40%、0.61%,重复性试验的RSD为0.28%;Y263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Y263的含量测定和稳定性研究。
OBJECTIVE To determine the content of Y263, a novel small molecule drug against psoriasis, by RP-HPLC and investigate its stability. Methods Kromasil-C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-water (50:50). The detection wavelength was 249 nm and the flow rate was 1.0 m L · min-1. Results Under the selected chromatographic conditions, Y263 could be completely separated from the adjacent impurity peaks. The linear relationship between peak area and 4 ~ 80μg · m L-1Y263 was good (r = 0.9999). The RSDs of high, medium and low concentrations were 0.80%, 0.57% and 1.53% respectively. The average recoveries and RSDs were 101.58%, 100.52%, 99.26% and 1.12%, 0.40% and 0.61% respectively. The RSD of repeatability test was 0.28% Strong light irradiation conditions stable. Conclusion The method is simple, rapid, specific and sensitive, suitable for the determination of Y263 content and stability.