| 引用本文: | 石云峰,孙逍,靖雅,杨伟峰.HPLC测定非诺贝特缓释胶囊的有关物质[J].中国现代应用药学,2019,36(6):706-709. |
| SHI Yunfeng,SUN Xiao,JING Ya,YANG Weifeng.Determination of Related Substances of Fenofibrate Extended Release Capsules by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(6):706-709. |
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| 摘要: |
| 目的 建立非诺贝特缓释胶囊有关物质的HPLC测定方法。方法 采用Kromasil-100-5 C18柱，流动相为乙腈-水（用磷酸调节pH至3.0）（67：33）；流速1.0 mL·min-1；检测波长为286 nm；柱温为40℃；进样量为10 μL。结果 非诺贝特与其他杂质的分离度较好，非诺贝特的线性范围为0.54~3.23 μg·mL-1（r=0.999 9），检测限为0.03 μg·mL-1。结论 建立的方法简便、准确、专属性强，可作为非诺贝特缓释胶囊有关物质的检测方法。 |
| 关键词: 非诺贝特缓释胶囊 有关物质 高效液相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.06.012 |
| 分类号:R917 |
| 基金项目: |
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| Determination of Related Substances of Fenofibrate Extended Release Capsules by HPLC |
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SHI Yunfeng, SUN Xiao, JING Ya, YANG Weifeng
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Zhejiang Institute for Food and Drug Control, Hangzhou 310025, China
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| Abstract: |
| OBJECTIVE To establish an HPLC method for related substances determination of Fenofibrate Extended Release capsules. METHODS The Kromasil-100-5 C18 column was used. The mobile phase was acetonitrile-water(pH 3.0) (67:33) at the flow rate of 1.0 mL·min-1. The detection wavelength was 286 nm and column temperature was 40℃. The injection volume was 10 μL. RESULTS The separation of fenofibrate and its related substances was good. The calibration curves of fenofibrate was linear in the range of 0.54-3.23 μg·mL-1(r=0.999 9), and its detection limit was 0.03 μg·mL-1. CONCLUSION The method is rapid, accurate and reliable for related substances determination of Fenofibrate Extended Release capsules. |
| Key words: Fenofibrate Extended Release capsules related substances HPLC |
