| HPLC法测定非诺贝特缓释片中非诺贝特 |
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| 引用本文： | 郭庆明,张晖,苏晓峰,陈宝来,萧伟.HPLC法测定非诺贝特缓释片中非诺贝特[J].国外医药(植物药分册),2014(5):497-499. |
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| 作者姓名： | 郭庆明 张晖 苏晓峰 陈宝来 萧伟 |
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| 作者单位： | 江苏康缘药业股份有限公司;中药制药过程新技术国家重点实验室; |
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| 基金项目： | 国家重点基础研究发展计划(973计划)项目(2012CB724001) |
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| 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。
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| 关 键 词： | 非诺贝特缓释片 非诺贝特 高效液相色谱 |
Determination of fenofibrate in Fenofibrate Sustained-release Tablets by HPLC |
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| Authors: | GUO Qing-ming ZHANG Hui SU Xiao-feng CHEN Bao-lai XIAO Wei |
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| Institution: | 1. Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China 2. State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China) |
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| Abstract: | 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. |
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| Keywords: | Fenofibrate Sustained-release Tablets fenofibrate HPLC |
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