高效液相色谱法测定对乙酰氨基酚口服溶液中苯甲酸钠含量  

Content Determination of Sodium Benzoate in Acetaminophen Oral Solution by HPLC

作　　者：李玲[1] 陈乃江[1] 姜燕[1] 

机构地区：[1]江苏省连云港市药品检验所,江苏连云港222006

出　　处：《中国药业》2016年第21期63-65,共3页China Pharmaceuticals

摘　　要：目的 建立测定对乙酰氨基酚口服溶液中防腐剂苯甲酸钠含量的高效液相色谱法。方法 色谱柱为Phenomenex Gemini C18柱（250 mm×4.6 mm,5μm）,流动相为乙腈-0.05 mol/L乙酸铵（15∶85）,流速为1.0 m L/min,检测波长为230 nm,柱温为30℃,进样量为20μL。结果 苯甲酸钠质量浓度在10.04～100.4μg/m L范围内与峰面积线性关系良好（r=0.999 9）,平均回收率为99.83%,RSD为0.99%（n=9）,苯甲酸钠检测限为1.3 ng。结论 该方法适用于对乙酰氨基酚口服溶液中苯甲酸钠的质量控制,可为该品种标准的提升提供参考。Objective To determine the content of sodium benzoate in acetaminophen oral solution by HPLC. Methods The Phenomenex Gemini Cls column（250 mm×4.6 mm, 5 p,m） was used, and the mobile phase was acetonitrile -0. 05 mol/L ammonium acetate（15 ： 85）. The flow rate was 1.0 mL/min and the detection wavelength was set at 230 nm. The column temperature was 30 ℃ and the injection volume was 20μL. Results The linear range of sodium benzoate was 10. 04- 100. 4 μg/mL（r=0. 999 9）, the average recovery was 99. 83% and RSD was 0. 99% （n =9）, the limit of detection was 1.3 ng. Conclusion The method is applicable to the quality control of sodium benzoate in acetaminophen oral solution, which can provide reference for the standard improvement.

关 键 词：高效液相色谱法 对乙酰氨基酚口服溶液 苯甲酸钠 防腐剂 含量测定 

分 类 号：R927.2[医药卫生—药学] R971.1