摘要
建立高效液相色谱波长切换法同时测定复方愈创木酚磺酸钾口服溶液中苯甲酸、山梨酸、羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯6种防腐剂含量。采用Waters XSelect HSS T3(250 mm×4.6 mm,5μm)色谱柱,甲醇作为流动相A,0.1%乙酸铵溶液(用乙酸调节pH值至4.5)作为流动相B,梯度洗脱,流量为1.0 mL/min,柱温为40℃,检测波长分别为226、256 nm,进样体积为10μL。6种防腐剂在质量浓度0.2~28.6μg/mL内与色谱峰面积呈良好线性关系,相关系数均为0.9999,精密度试验测试结果的相对标准偏差为0.1%~0.6%,样品加标平均回收率为98.8%~102.2%。该方法操作简单,专属性强,准确度高,重复性好,可用于复方愈创木酚磺酸钾口服溶液的防腐剂检测,为生产企业的处方、生产工艺和质量标准的把控提供参考作用。
A high performance liquid chromatography with wavelength switching method was established to simultaneously determine the contents of benzoic acid,sorbic acid,methylparaben,ethylparaben,propylparaben and butylparaben in compound guaiacol potassium sulfonate oral solution.Waters XSelect HSS T3(250 mm×4.6 mm,5μm)chromatographic column was used.Methanol was used as mobile phase A,and 0.1%ammonium acetate solution(adjusted to pH 4.5 with acetic acid)was used as mobile phase B.Gradient elution was performed at a flow rate of 1.0 mL/min and a column temperature of 40°C.The detection wavelengths were 226 nm and 256 nm,respectively.The injection volume was 10μL.It showed a good linear relationship with the chromatographic peak area in the range of 0.2-28.6μg/mL of the six preservatives,and the correlation coefficients were all 0.9999.The relative standard deviation of the test results were 0.1%-0.6%.The average recoveries rate of the samples were 98.8%-102.2%.This method is simple,accurate,highly accurate and reproducible,which is suitable for determination of composition and content of preservatives in compound potassium guaiacol sulfonate oral solution.
作者
杨娜
李丹凤
刘涛
林里明
李仁乔
张明丽
许有诚
YANG Na;LI Danfeng;LIU Tao;LIN Liming;LI Renqiao;ZHANG Mingli;XU Youcheng(Guangxi Institute For Drug Control,Nanning 530021,China;Guangxi Medical Products Administration,Nanning 530029)
出处
《化学分析计量》
CAS
2024年第6期29-33,共5页
Chemical Analysis And Meterage
基金
2023年广西壮族自治区药品监督管理局直属单位药品安全科研项目计划[桂药监科直属(2023)048号]。
关键词
复方愈创木酚磺酸钾口服溶液
防腐剂
波长切换
高效液相色谱
compound guaiacol potassium sulfonate oral solution
preservatives
wavelength switching
high performance liquid chromatography
