摘要
目的:建立高效液相色谱法测定罗氟司特原料药含量的分析方法。方法选用Agilent C18色谱柱(250mm ×4.6mm,5μm);以0.005mol · L ^-1甲酸铵溶液(pH 3.5)-乙腈(40∶60,v/v)为流动相;柱温30℃;流速:1.0mL· min ^-1;检测波长:250nm。结果罗氟司特的线性关系良好(25.05~100.2μg· mL^ -1,r=0.9998);平均加样回收率为100.0%,RSD=1.0%(n=9);检测限与定量限分别为1.7ng和5.0ng;重复性、中间精密度均符合要求。结论本方法专属性强,简捷,准确,可用于罗氟司特原料药的含量测定。
OBJECTIVE To establish a RP-HPLC method for the determination of the content of Roflumilast crude drug.METHODS The analysis was performed on a C18 column(250mm ×4.6mm,5μm)with a mobile phase consisting of ammonium formate buffer (pH 3.5)-acetonitrile (40∶60,v/v) at the flow rate of 1.0mL· min^ -1.The detection wavelength was set at 250nm,and column temperature was 30℃.RESULTS Roflumilast revealed good linearity over the range of 25.05 ~100.2μg · mL^-1 ( r =0.9998 ) with an average recovery of 100.0% ( RSD =1.0%,n=9).The LOD and LOQ were 1.7ng and 5.0ng,respectively.Repeatability and intermediate precision both met the requirements.CONCLUSION This method is simple,accurate and specific,and it could be used for the determination of roflumilast.
出处
《海峡药学》
2014年第4期52-54,共3页
Strait Pharmaceutical Journal
基金
2013年度大学生创新创业校级项目(No.02640557)