咳露口服液中苯甲酸钠含量测定的方法学研究

Determination of sodium benzoate in Kelu Oral Liquid

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。

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 （250mm×4.6mm,5μm）, with mobile phase of acetonitrile 1.0 mL·L^-1 phosphoric 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.