反相高效液相色潽法测定WF-208的含量和有关物质  

Determination of WF-208 and its related substances by RP-HPLC

作　　者：崔红霞[1] 霍艳双[1] 李清[1] 李伟[1] 王曼曼[1] 陈晓辉[1] 毕开顺[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2012年第17期2069-2071,2090,共4页Chinese Journal of New Drugs

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。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 aeetonitrile-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.

关 键 词：反相高效液相色谱法 WF-208 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]