| 咳露口服液中苯甲酸钠含量测定的方法学研究 |
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| 引用本文： | 杨东花,刘峰,黄壮壮.咳露口服液中苯甲酸钠含量测定的方法学研究[J].西北药学杂志,2012,27(5):418-419. |
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| 作者姓名： | 杨东花 刘峰 黄壮壮 |
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| 作者单位： | 陕西中医学院;陕西步长制药有限公司;陕西省中药制药工程技术研究中心 |
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| 基金项目： | 国家重点新产品计划项目(编号:2008GRG00010);陕西省重点新产品计划项目(编号:2008XCP-09);陕西省“13115”科技创新工程技术研究中心(编号:2010ZDGC-20) |
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| 摘 要： | 目的建立HPLC法测定咳露口服液中苯甲酸钠含量的方法,为提高该制剂的质量标准提供技术参考。方法采用高效液相色谱法,色谱柱为Hibar C18(250mm×4.6mm,5μm);以乙腈-1mL.L-1磷酸溶液(30∶70)为流动相;流速为1.0mL.min-1;检测波长为230nm。结果在上述色谱条件下,样品中苯甲酸钠峰与其他峰能够达到基线分离,苯甲酸钠在0.216 2～1.297 2μg范围内线性关系良好,线性回归方程为Y=4 598 557 X+64 873(r=0.999 9),平均回收率为98.2%,RSD为1.6%(n=6)。结论该方法操作简单,准确,重复性好,为控制咳露口服液中防腐剂苯甲酸钠的含量提供了重要依据。
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| 关 键 词： | 高效液相色谱法 咳露口服液 苯甲酸钠 |
Determination of sodium benzoate in Kelu Oral Liquid |
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| YANG Donghua,LIU Feng,HUANG Zhuangzhuang.Determination of sodium benzoate in Kelu Oral Liquid[J].Northwest Pharmaceutical Journal,2012,27(5):418-419. |
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| Authors: | YANG Donghua LIU Feng HUANG Zhuangzhuang |
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| Institution: | 1(1.Shaanxi University of Chinese Medicine,Xianyang 712046,China;2.Shaanxi Buchang Pharmaceutical Co.,LTD,Xianyang 712000,China;3.Shaanxi Engineering and Research Center for Traditional Chinese Medicine,Xianyang 712000,China) |
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| Abstract: | Objective To establish an HPLC method for the determination of sodium benzoate in Kelu Oral Liquid and to provide a technical reference for the quality standards.Methods The HPLC was performed on Hibar C18(250 mm×4.6 mm,5 μm),with mobile phase of acetonitrile 1.0 mL·L-1phosphoric acid(30∶70) at flow rate of 1.0 mL·min-1,and detection wavelength of 230 nm.Results Under optimal conditions,the peak of sodium benzoate and other peaks in samples can be separated from baseline.A linearity of sodium benzoate was obtained from 0.216 2 to 1.297 2 μg with good correlation and the regression equation was Y=4 598 557X+64 873(r=0.999 9).The average recovery was 98.2%,and RSD was 1.6%(n=6).Conclusion The method is simple,accurate,and reproducible.It could be used in the control of sodium benzoate in Kelu Oral Liquid. |
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| Keywords: | HPLC Kelu Oral Liquid sodium benzoate |
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