盐酸氨溴索口服溶液中苯甲酸钠的含量测定方法学研究  

Determination of sodium benzoatein ambroxol hydrochloride oral solution

作　　者：李小安[1,2] 吴少平 刘海静 徐长岭[3] 

机构地区：[1]陕西中医学院,陕西咸阳712046 [2]陕西省食品药品检验所,陕西西安710061 [3]西安医学院,陕西西安710061

出　　处：《安徽医药》2011年第1期40-42,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立RP-HPLC法测定盐酸氨溴索口服溶液中苯甲酸钠含量的方法,为本制剂的质量标准提高提供技术参考。方法采用高效液相色谱法,色谱柱为Diamonsil-C18(4.6mm×150mm,5.0μm),以0.02mol.L-1乙酸铵-甲醇(95∶5)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0.3736～2.2416μg范围内线性关系良好,线形回归方程为A=1620 056C+77979(r=0.9997)。供试品溶液在24h内稳定,平均回收率为99.12%,RSD为1.02%(n=9)。结论本方法操作简单,准确,重现性好,为控制盐酸氨溴索口服溶液中防腐剂苯甲酸钠的质量提供了重要依据。Aim To establish an RP-HPLC method for the determination of sodium benzoate in ambroxol hydrochloride oral solution,and to provide technical reference for the quality standards.Methods The RP-HPLC was performed on Diamonsil-C18 column（4.6 mm×150 mm,5.0 μm）,with mobile phase of 0.02 mol·L-1 ammonium acetate-methanol（95∶ 5）at a flow rate of 1.0 ml·min-1,and detection wavelength of detector 230 nm.Results Under optimal conditions,the peak of sodium benzoate and other peaks in samples can be separated from the baseline.A linearity of sodium benzoate was obtained from 0.373 6 μg to 2.241 6 μg with good correlation,and the regression equation was A=1 620 056C＋77 979（r=0.999 7）.The average recovery was 99.12%,and RSD was 1.02%（n=9）.Conclusion The method is simple,accurate,and reproducible.It takes a great role in the control of sodium benzoate in ambroxol hydrochloride oral solution.

关 键 词：HPLC法 盐酸氨溴索口服溶液 苯甲酸钠 

分 类 号：R927.2[医药卫生—药学]