HPLC法快速检测苦参素注射液中8个抑菌剂及苯甲醛  

HPLC rapid screening and simultaneous determination of eight bacteriostatic agents and benzaldehyde in oxymatrine injection

作　　者：吴春敏[1] 朱精英[1,2] 池文杰[1] 罗嵚[1,2] 陈海滨[1] 

机构地区：[1]福建省药品检验所,福州350001 [2]福建中医药大学,福州350108

出　　处：《药物分析杂志》2012年第7期1200-1204,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：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 an HPLC method for rapid screening and simultaneous determination of eight bacteriostatic agents （ benzyl alcohol, phenol, benzoic acid, sorbic acid, methyl p - hydroxybenzoate, ethyl p - hydroxybenzoate, propyl p- hydroxybenzoate, butyl p- hydroxybenzoate and benzaldehyde from degradation prod- uct of benzyl alcohol in oxymatrine injection. Methods： The analysis was performed on Welch Materials XB -C18 column（4. 6 mm ×250 mm,5 μm） with the mobile phase consisting of acetonitrile -0. 02 mol. L^-1 ammonium ac- etate（ glacial acetic acid adjustable pH 5.0） in gradient mode. The detection wavelength was set at 211 nm for ben- zyl alcohol and phenol, 225 nm for benzoic acid, 248 nm for benzaldehyde and 256 nm for sorbic acid, methyl p - hydroxybenzoate, ethyl p - hydroxybenzoate, propyl p - hydroxybenzoate, butyl p - hydroxybenzoate. Result： Nine constituents showed good linearity （r 〉 0. 9998） in the range of the test concentration. The average recoveries of the method were between 95.6% and 102.2%. Conclusion： The method is sensitive, rapid and accurate with good repeatability, injection. which can be used for rapid screening and determination of the content of bacteriostatic agents ininjection.

关 键 词：高效液相色谱 快速检测苦参素注射液 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 苯甲醛 

分 类 号：R917[医药卫生—药物分析学]