HPLC法测定三苯双脒肠溶片的含量及有关物质

Determination of tribendimidine and related substances in the enteric-coated of tribendimidine by HPLC

目的建立三苯双脒肠溶片的含量及有关物质检测的高效液相色谱方法。方法色谱柱为Agilent Zorbax Extend-C18(4.6×150mm,5μm),流动相为乙腈-水-三乙胺(75∶25∶0.35),检测波长为388nm,流速为0.8mL.min-1。结果三苯双脒的浓度在0.0253～0.1516mg·mL-1范围内有良好的线性关系(r=0.9999),平均回收率为99.38%,定量限为30.36ng,检测限为9.11ng。结论高效液相色谱法测定三苯双脒肠溶片中的三苯双脒含量和有关物质,该方法准确度和精密度高,适合应用于该制剂的质量控制。

OBJECTIVE To establish an HPLC method for the determination of tribendimidine in the entric-coated of Tribendimidine and its related substances.METHODS Chromatograghic column was Agilent Zorbax Extend-C18 （4.6×150mm,5μm）,the mobile phase was acetenitrile-water-trieth （75：25：0.35）,and detection wavelength was 388nm,the flow rate was 0.8mL·min-1.RESULTS A good linearity was abtained from 0.0253～0.1516mg·mL-1（r=0.9999）,the average recovery was 99.38%.CONCLUSION The developed HPLC was proved to meet the requirement of detecting the content of the tribendimidine and related substances of the enteric-coated of Tribendimidine.The method had very good accuracy and precision,It was suitable for the quality control of the enteric-coated of Tribendimidine.