hplc测定非诺贝特缓释胶囊的有关物质.pdfVIP

HPLC 测定非诺贝特缓释胶囊的有关物质  石云峰，孙逍，靖雅，杨伟峰*(浙江省食品药品检验研究院，杭州 310025) 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 1；检测波长为286 nm；柱温为40 ℃；进样量为10 μL 。结果 非诺贝特 磷酸调节pH 至3.0)(67 ∶33)；流速1.0 mL·min 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 中图分类号：R917 文献标志码：B 文章编号：1007-7693(2019)06-0706-04 DOI: 10.13748/ki.issn1007-7693.2019.06.012 引用本文: 石云峰, 孙逍, 靖雅, 等. 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. Determination of Related Substances of Fenofibrate Extended Release Capsules by HPLC * SHI Yunfeng, SUN Xiao, JING Ya, YANG Weifeng (Zhejiang Institute for Food and Drug Control, Hangzhou 310025, China) 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. KEYWORDS: Fenofibrate Extended Release capsules; related substances; HPLC 非诺贝特为第二代苯氧芳酸类药物，于 1974 生药业有限公司(B 企业) ，批号：170312，170215； 年由法国 Laboratoires Fournier S