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盐酸氨溴索口服溶液中苯甲酸钠的含量测定方法学研究
引用本文:李小安,吴少平,刘海静,徐长岭.盐酸氨溴索口服溶液中苯甲酸钠的含量测定方法学研究[J].安徽医药,2011,15(1):40-42.
作者姓名:李小安  吴少平  刘海静  徐长岭
作者单位:陕西中医学院,陕西,咸阳,712046;陕西省食品药品检验所,陕西,西安,710061;陕西省食品药品检验所,陕西,西安,710061;西安医学院,陕西,西安,710061
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(4.6 mm×150 mm,5.0 μm),以0.02 mol·L-1乙酸铵-甲醇(95:5)为流动相,流速为1.0 ml·min-1,检测波长为230...

关 键 词:HPLC法  盐酸氨溴索口服溶液  苯甲酸钠

Determination of sodium benzoatein ambroxol hydrochloride oral solution
LI Xiao-an,WU Shao-ping,LIU Hai-jing,XU Chang-ling.Determination of sodium benzoatein ambroxol hydrochloride oral solution[J].Anhui Medical and Pharmaceutical Journal,2011,15(1):40-42.
Authors:LI Xiao-an  WU Shao-ping  LIU Hai-jing  XU Chang-ling
Institution:1.Shaanxi College of Traditional Chinese Medicine,Xianyang 712046,China;2.Shanxi Institute forFood and Drug Control,Xi'an 710061,China;3.Xi'an Medical College,Xi'an 710061,China)
Abstract: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.
Keywords:HPLC  ambroxol hydrochloride oral solution  sodium benzoate
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