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HPLC法测定盐酸苯氟雷司片的含量和有关物质
引用本文:李芳明,张娜,孙艳华,宋慧智.HPLC法测定盐酸苯氟雷司片的含量和有关物质[J].齐鲁药事,2009,28(6):331-333.
作者姓名:李芳明  张娜  孙艳华  宋慧智
作者单位:1. 山东大学药学院,山东,济南,250100;山东新华制药股份有限公司,山东,淄博,255005
2. 山东大学药学院,山东,济南,250100
3. 山东新华制药股份有限公司,山东,淄博,255005
摘    要:目的建立高效液相色谱法,测定盐酸苯氟雷司片的含量并考察有关物质。方法采用Agilent ZORBAX SB-C18(4.6×250mm,5μm)色谱柱,以0.02mol.L-1磷酸二氢钾(含高氯酸0.2%,氢氧化钠试液调pH 5.0)-乙腈(47∶53)为流动相,含量检测波长为232nm,有关物质检测波长为210nm,流速为1.0mL.min-1,柱温为35℃。结果盐酸苯氟雷司的浓度在0.05和0.3g.L-1有良好的线性关系(r=0.9999),样品的平均回收率为100.1%,RSD为0.29%。结论本法简便、准确,灵敏度高,适用于盐酸苯氟雷司片的质量控制。

关 键 词:高效液相色谱法  盐酸苯氟雷司片  含量测定  有关物质

Determination of benfluorex in Benfluorex Hydrochloride Tablets and its related substances by HPLC
LI Fang-ming,ZHANG Na,SUN Yan-hua,SONG Hui-zhi.Determination of benfluorex in Benfluorex Hydrochloride Tablets and its related substances by HPLC[J].qilu pharmaceutical affairs,2009,28(6):331-333.
Authors:LI Fang-ming  ZHANG Na  SUN Yan-hua  SONG Hui-zhi
Institution:LI Fang-ming1,2,ZHANG Na1,SUN Yan-hua2,SONG Hui-zhi2
Abstract:OBJECTIVE To establish an HPLC method for the determination of benfluorex in Benfluorex Hydrochloride Tablets and its related substances. METHODS A stable HPLC method was established,and the chromatography was accomplished on an Agilent ZORBAX SB--C18 column (4.6 × 250mm, 5μm), the mobile phase consisted of 0.02mol . L^-1 potassium dihydrogen phosphate, (containing 0. 2% perchloric acid,adjusted pH 5.0 with sodium hydroxide)--acetonitrile (47 : 53),the detection wavelength of content determination was 232nm,the detection wavelength of its related substances was 210nm;the flow rate was 1.0mL . min^-1 the column temperature was 35℃. RESULTS Relationship was observed in the concentration range of 0. 05 and 0.3g.L^-1 with the correlation coefficient of 0. 9999, the average recovery of the benfluorex hydrochloride was 100. 1%, RSD =0. 29%. CONCLUSION The method was simple,accurate and sensitive,and it was suitable for the quality control of Benfluorex Hydrochloride Tablets.
Keywords:HPLC  Benfluorex Hydrochloride Tablets  determination  related substance  
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