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目的:建立快速筛查和同时测定苦参素注射剂中8种抑菌剂(苯甲醇、苯酚、苯甲酸、山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯)及苯甲醇降解产物———苯甲醛含量的高效液相色谱法。方法:应用WelchMaterials XB-C18色谱柱(4.6 mm×250 mm,5μm);流动相为乙腈-0.02 mol.L-1醋酸铵(冰醋酸调pH至5.0)梯度洗脱,流速1.0 mL.min-1,检测波长为211 nm(苯甲醇、苯酚),225 nm(苯甲酸),248 nm(苯甲醛),256 nm(山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯)。结果:9种成分的峰面积与浓度的线性关系良好(r>0.9998),加样回收率为95.6%～102.2%。结论:本方法灵敏,快捷,准确,重复性好,可用于注射剂中抑菌剂的快速筛查与含量分析。
OBJECTIVE: To establish a rapid screening and simultaneous determination of eight antibacterial agents (benzyl alcohol, phenol, benzoic acid, sorbic acid, methyl paraben, ethyl paraben, propyl paraben Ester, p-hydroxybenzoate) and benzyl alcohol degradation products --- benzaldehyde content of high performance liquid chromatography. Methods: The mobile phase was eluted with a gradient of acetonitrile-0.02 mol·L-1 ammonium acetate (adjusted to pH 5.0 with glacial acetic acid) using a WelchMaterials XB-C18 column (4.6 mm × 250 mm, 5 μm) at a flow rate of 1.0 mL · min- 1, detection wavelength is 211 nm (benzyl alcohol, phenol), 225 nm (benzoic acid), 248 nm (benzaldehyde), 256 nm (sorbic acid, methyl paraben, ethyl paraben, Propyl benzoate, butyl p-hydroxybenzoate). Results: The linear relationship between the peak area and the concentration of the nine components was good (r> 0.9998). The recoveries were 95.6% -102.2%. Conclusion: The method is sensitive, rapid, accurate and reproducible. It can be used in the rapid screening and content analysis of antibacterial agents in injection.