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HPLC法测定山楂红曲胶囊中洛伐他汀
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  • 英文篇名:Improvement of determination method of lovastatin in Monascus Capsules
  • 作者:崔琳 ; 牛向伟 ; 张菁菁 ; 闫春风
  • 英文作者:CUI Lin;NIU Xiangwei;ZHANG Jingjing;YAN Chunfeng;Jingfukang Pharmaceutical Group Co., Ltd.;Hebei Provincial Engineering Technology Research Center for New Pharmaceutical Excipients in Traditional Chinese Medicine;
  • 关键词:山楂红曲胶囊 ; 洛伐他汀内酯 ; 酸式洛伐他汀 ; HPLC
  • 英文关键词:Monascus Capsules;;Lovastatin lactone;;acid type lovastatin;;HPLC
  • 中文刊名:YWPJ
  • 英文刊名:Drug Evaluation Research
  • 机构:颈复康药业集团有限公司;河北省中药新辅料工程技术研究中心;
  • 出版日期:2019-04-08
  • 出版单位:药物评价研究
  • 年:2019
  • 期:v.42
  • 语种:中文;
  • 页:YWPJ201904012
  • 页数:3
  • CN:04
  • ISSN:12-1409/R
  • 分类号:77-79
摘要
目的建立山楂红曲胶囊中洛伐他汀的处理及含量测定方法。方法色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),紫外检测波长238 nm,柱温25℃,体积流量1.0 mL/min,流动相为甲醇:0.1%磷酸溶液(75:25)。结果洛伐他汀质量浓度在2.04~306μg/mL与峰面积线性关系良好,平均回收率为98.58%,RSD=1.12%(n=9)。结论该方法准确、简便,可用于山楂红曲胶囊的质量控制。
        Objective To establish a method of processing and determining for the lovastatin in Monascus Capsules. Methods Inspecting the influence of water bath temperature to the transformation of lovastatin structure, on the basis of "content determination standards for lovastatin in the health food". Chromatographic separation was achieved on a Kromasil C18 analytical column(250 mm × 4.6 mm, 5 μm), and the detection wavelength was set at 238 nm, maintained at 25 ℃. The prepared mobile phase was delivered at a flow rate of 1.0 mL/min. The mobile phase consisted of 75% Methano and 25% Phosphoric acid(0.1%).Results the linear range was 2.04 to 306 μg/mL. The average recovery was 98.58%. The precision was 1.12%(n = 9). Conclusion The improved method for determination is that transforming acid structure of lovastatin into lactone structure, the method which is accurate and simple can be applied to control the quality of Monascus Capsules.
引文
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