【摘要】 目的:建立RP-HPLC法测定WF-208的含量并进行有关物质检查。方法:采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈-甲醇-水(62∶20∶18);流速:1.0 mL.min-1;检测波长:238 nm;柱温:30℃。结果:WF-208在5.00～50.0 mg.L-1范围内线性关系良好(r=0.999 7),平均回收率为99.8%(RSD=0.3%),WF-208与有关物质得到良好的分离,检测限为20μg.L-1。结论:该方法操作简单,重复性好,专属性强,可用于WF-208原料药的含量测定和有关物质的检查。更多还原

【Abstract】 Objective: To establish a RP-HPLC method for determining the contents of WF-208 and its related substances.Methods: Diamonsil C18(250 mm×4.6 mm,5 μm) was adopted with acetonitrile-methanol-water(62∶20∶18) as the mobile phase.The flow rate was 1 mL·min-1,the wavelength was set at 238 nm and the column temperature at 30 ℃.Results: The linearity of WF-208 was in the range of 5.00 to 50.0 mg·L-1(r=0.999 7).The average recovery was 99.8% with RSD of 0.3%.The related substances of WF-208 were completely separated from WF-208,and the limit of detemination(LOD) was 20 μg·L-1.Conclusion: The method is proven to be reproducible,specific and suitable for the determination of WF-208 and its related substances.更多还原