| 反相高效液相色潽法测定WF-208的含量和有关物质 |
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| 引用本文： | 崔红霞,霍艳双,李清,李伟,王曼曼,陈晓辉,毕开顺.反相高效液相色潽法测定WF-208的含量和有关物质[J].中国新药杂志,2012(17):2069-2071,2090. |
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| 作者姓名： | 崔红霞 霍艳双 李清 李伟 王曼曼 陈晓辉 毕开顺 |
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| 作者单位： | 沈阳药科大学药学院 |
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| 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。
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| 关 键 词： | 反相高效液相色谱法 WF-208 含量测定 有关物质 |
Determination of WF-208 and its related substances by RP-HPLC |
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| CUI Hong-xia,HUO Yan-shuang,LI Qing,LI Wei,WANG Man-man,CHEN Xiao-hui,BI Kai-shun.Determination of WF-208 and its related substances by RP-HPLC[J].Chinese Journal of New Drugs,2012(17):2069-2071,2090. |
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| Authors: | CUI Hong-xia HUO Yan-shuang LI Qing LI Wei WANG Man-man CHEN Xiao-hui BI Kai-shun |
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| Affiliation: | (School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China) |
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| 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. |
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| Keywords: | RP-HPLC WF-208 determination related substances |
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