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《化学分析计量》 2022年第07期
DOI:10.3969/j.issn.1008-6145.2022.07.005
高效液相色谱法测定复方甘草口服溶液中8种防腐剂
曾庆花,黄慧,杨娜,李智明,邓鸣
广西食品药品检验所,南宁 530021 
Determination of 8 preservatives in Compound Glycyrrhiza Oral Solutionby high performance liquid chromatography
ZENG Qinghua, HUANG Hui, YANG Na, LI Zhiming, DENG Ming
Guangxi Institute for Food and Drug Control, Nanning 530021, China 
摘要:建立高效液相色谱法测定复方甘草口服溶液中苯甲醇、苯酚、苯甲酸、山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯和对羟基苯甲酸丁酯8种防腐剂。样品经体积分数为50%的甲醇溶液稀释后,以SHISEIDO CAPCELL MGⅡC18色谱柱(250 mm×4.6 mm, 5μm)为分离柱,以乙腈-0.02 mol/L乙酸铵溶液(用冰乙酸调至pH 5.0)为流动相,梯度洗脱,流量为1.0 mL/min,检测波长分别为211 nm (苯甲醇、苯酚)、225 nm (苯甲酸)、256 nm (山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯和对羟基苯甲酸丁酯),柱温为30℃。苯甲醇的质量浓度在8.0~160.0μg/mL范围内,山梨酸的质量浓度在3.0~150.0μg/mL范围内,苯酚、苯甲酸的质量浓度在3.0~300.0μg/mL范围内,对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯的质量浓度在0.5~50.0μg/mL范围内与色谱峰面积线性关系良好,相关系数均不小于0.999 7,检出限为0.01~2.0 μg/mL。样品加标回收率为98.3%~105.1%,测定结果的相对标准偏差为0.8%~6.5%(n=9)。该方法简便、准确,分离效果好。 
Abstract:A method was established for simultaneous determination of benzyl alcohol, phenol, benzoic acid, sorbic p p p p acid, methyl -hydroxybenzoate, ethyl -hydroxybenzoate, propyl -hydroxybenzoate and butyl -hydroxybenzoate in Compound Glycyrrhiza Oral Solution by high performance liquid chromatography. The samples were diluted with 50% methanol solution. SHISEIDO CAPCELL MGⅡC18 column (250 mm×4.6 mm, 5μm) was used as separation column with acetonitrile-0.02 mol/L ammonium acetate (glacial acetic acid was used to adjust pH to 5.0) as the mobile phase, gradient elution, and the flow rate was 1.0 mL/min. The detection wavelength was set at 211 nm for benzyl alcohol and phenol, 225 nm for benzoic acid, 256 nm for sorbic acid, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p p -hydroxybenzoate, butyl -hydroxybenzoate, and the column temperature was 30℃. The mass concentration of benzyl alcohol in the range of 8.0-160.0μg/mL, sorbic acid in the range of 3.0-150.0μg/mL, phenol and benzoic acid in the p p p range of 3.0-300.0μg/mL, methyl -hydroxybenzoate, ethyl -hydroxybenzoate, propyl -hydroxybenzoate and butyl p-hydroxybenzoate in the range of 0.5-50.0μg/mL had a good linear relationship with the chromatographic peak area, the correlation coefficients were not less than 0.999 7, and the detection limits were 0.01-2.0μg/mL. The recoveries of spiked samples were 98.3%-105.1%, and the relative standard deviations of determination results were 0.8%-6.5%(n=9). The method is simple, accurate with good separation. 
关键词:高效液相色谱法;复方甘草口服溶液;防腐剂 
Keywords:high performance liquid chromatography; Compound Glycyrrhiza Oral Solution; preservatives 
基金:广西药品监督管理局2020年直属单位药品安全科研项目(桂药监科2020–直属) 
本文引用格式:
曾庆花,黄慧,杨娜,等.高效液相色谱法测定复方甘草口服溶液中8种防腐剂[J].化学分析计量,2022,31(7):18.
ZENG Qinghua,HUANG Hui,YANG Na,et al. Determination of 8 preservatives in Compound Glycyrrhiza Oral Solution by high performance liquid chromatography[J]. Chemical Analysis and Meterage,2022,31(7):18. 

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