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目的:建立快速筛查和同时测定苦参素注射液中8个抑菌剂(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Welch Materials XB-C18色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.02 mol.L-1醋酸铵溶液(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个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 8 antibacterial agents (benzyl alcohol, phenol, benzoic acid, sorbic acid, methyl paraben, ethyl paraben, p-hydroxybenzoate Propyl, 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 Welch Materials XB-C18 column (4.6 mm × 250 mm, 5 μm) at a flow rate of 1.0 mL. min-1, detection wavelength was 211 nm (benzyl alcohol, phenol), 225 nm (benzoic acid), 248 nm (benzaldehyde), 256 nm (sorbic acid, methylparaben, ethylparaben, Propyl p-hydroxybenzoate, butyl p-hydroxybenzoate). Results: The linear relationship between the peak areas of nine components and the concentration was good (r> 0.9998). The average 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.