高效液相色谱法测定萘哌地尔制剂的含量

    侯鹏高, 吕长淮

    侯鹏高, 吕长淮. 高效液相色谱法测定萘哌地尔制剂的含量[J]. 蚌埠医科大学学报, 2012, 36(11): 1330-1331,1335.
    引用本文: 侯鹏高, 吕长淮. 高效液相色谱法测定萘哌地尔制剂的含量[J]. 蚌埠医科大学学报, 2012, 36(11): 1330-1331,1335.
    HOU Peng-gao, Lü Chang-huai. Determination of naftopidil preparation by HP LC method[J]. Journal of Bengbu Medical University, 2012, 36(11): 1330-1331,1335.
    Citation: HOU Peng-gao, Lü Chang-huai. Determination of naftopidil preparation by HP LC method[J]. Journal of Bengbu Medical University, 2012, 36(11): 1330-1331,1335.

    高效液相色谱法测定萘哌地尔制剂的含量

    基金项目: 

    国家药典委员会药品标准提高项目(972-4)

    详细信息
      作者简介:

      侯鹏高(1957- ), 男, 高级讲师.

    Determination of naftopidil preparation by HP LC method

    • 摘要: 目的:建立高效液相色谱法测定萘哌地尔制剂含量的分析方法。方法:采用Waters C18色谱柱(150. 0 mm4. 6 mm, 5m), 流动相为乙腈-甲醇-0. 02 mol/L乙酸钠缓冲液(40∶30∶30), 流速为1 ml/min, 检测波长为283 nm, 柱温为30℃, 进样量为10l。结果:萘哌地尔在0. 998~29. 940g/ml具有良好的线性关系(r=0. 999 9);高、中、低3个浓度的平均回收率分别为101. 61%、100. 44%和99. 28%, RSD(%)分别为0. 25、0. 12和0. 44。结论:高效液相色谱法简便准确, 重复性好, 适用于萘哌地尔制剂的质量控制。
      Abstract: Objective: To establish an HP LC method for determination of naftopidil preparations. Methods: In this study, Waters C18 column(150. 0 mm 4. 6 mm, 5 m) was used, with acetonitrile-methanol-0. 02 mol/L sodium acetate(40∶ 30∶ 30) as mobile phase at a flow rate of 1. 0 ml/min, and the detection wavelength was 283 nm. The injection volume was 10 l and column temperature was set at 30 ℃. Results: The calibration curve was over the range of 0. 998-29. 940 g/ml(with the correlation coefficient of 0. 9999) . The mean recovery of three concentration were 101. 61%, 100. 44% and 99. 28% while the RSD(%) was 0. 25, 0. 12 and 0. 44, respectively. Conclusions: The method is simple, accurate, reproducible and suitable for the quality control of Naftopidil preparations.
    • [1] .肖溶,张丹,杜培刚,等.Chiralpak AD-RH 手性柱直接拆分萘哌地尔对映体[J].药物分析杂志,2009,29(12):1989.
      [1] [2] .国家食品药品监督管理局标准(试行)[S].YBH01922005
      [2] [3] .国家药品监督管理局标准(试行)[S].YBH01882003
      [3] [4] .国家药品监督管理局标准(试行)[S].WS-373(X-314)-2002
      [4] [5] .国家食品药品监督管理局国家药品标准[S].WS1-(X-011)-2004Z
      [5] [6] .张岱州,李洁,巴晓革,等.萘哌地尔分散片中有关物质的HPLC 法测定[J].中国医药工业杂志,2010,41(11):854-855.
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    出版历程
    • 收稿日期:  2012-06-30
    • 刊出日期:  2012-11-14

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