摘要
目的采用HPLC法测定非诺贝特缓释片中非诺贝特。方法采用DikmaC18色谱柱（200mm）〈4．6mm，5μm）；流动相：甲醇-水（90：10）；检测波长：288nm；柱温：25℃；体积流量：1．0μL／mim进样量10μL。结果非诺贝特在2．0～12．0μg／mL与其峰面积呈良好的线性关系（F=0．9999）；检测限和定量限分别为10、30ng／mL；平均回收率为99．86％，RSD值为0．72％（n=9）。结论该方法准确、简便，可用于非诺贝特缓释片中非诺贝特的质量控制。
Objective To establish an HPLC method for determining fenofibrate in Fenofibrate Sustained-release Tablets. Methods HPLC was carried out on a Dikma Cls column （200 mm x 4.6 mm, 5 μm） with methanol - water （90 ： 10） as mobile phase. The detection wavelength was set at 288 nm. The injection volume was 20 μL at the flow rate of 1.0 μL/min. The temperature of column was set at 25 ℃. Results There were good linear relationship of fenofibrate in the range of 2 - 12μg/mL （r = 0.999 9）. The limits of detection and quantitation were 10 and 30 ng/mL, respectively. The average recoveries was 99.86% with RSD value of 0.72% （n = 9）. Conclusion The method is accurate and simnle for aualitv control of fenofibrate in Fenofibrate Sustained-release Tablets.
出处
《现代药物与临床》
CAS
2014年第5期497-499,共3页
Drugs & Clinic
基金
国家重点基础研究发展计划(973计划)项目(2012CB724001)
