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作 者:廖乃英 袁孝晔 LIAO Naiying;YUAN Xiaoye(Guangxi Medical College,Nanning 530023,China;Guangxi Nanning Rexim Pharmaceutical Company,Nanning 530100,China)
机构地区:[1]广西卫生职业技术学院,南宁530023 [2]广西南宁赢创美诗药业有限公司,南宁530100
出 处:《中国现代应用药学》2020年第3期321-325,共5页Chinese Journal of Modern Applied Pharmacy
摘 要:目的建立胶束电动毛细管色谱二极管阵列检测法(MEKC-DAD)同时测定不同厂家的麻杏止咳糖浆中苯甲酸、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、对羟基苯甲酸丁酯等6种防腐剂的含量。方法采用胶束电动毛细管分离模式,用未涂渍的标准熔融石英毛细管柱(75μm×64 cm,有效长度56 cm)为分离通道;背景电解质溶液:15 mmol·L^-1硼砂-60 mmol·L^-1硼酸-50 mmol·L^-1 SDS;检测波长195 nm;运行电压:15 kV;运行温度:20℃;压力进样:50 mbar,5 s。结果各化合物的浓度与峰面积的线性关系良好(r≥0.9993);精密度、稳定性试验的RSD<2.0%;加样回收率范围为98.7%~101.2%(n=9)。5家企业共10批样品均未检出山梨酸和对羟基苯甲酸酯类;5家企业样品的苯甲酸含量与处方相符。结论本方法可用于麻杏止咳糖浆中防腐剂的检测,为其生产工艺和质量控制提供有意义的实验数据和参考依据。OBJECTIVE To establish a micellar electrokinetic chromatography with diode array detection(MEKC-DAD)method for simultaneous determination of six preservatives including benzoic acid,sorbic acid,methylparaben,ethylparaben,propylparaben and butyl-p-hydroxybenzoate in Maxing Zhike syrup.METHODS Based on the mode of MEKC,an uncoated fused silica capillary(75μm×64 cm,56 cm of effective length)was adopted,and 15 mmol·L^-1 borax-60 mmol·L^-1 boric acid-50 mmol·L^-1 SDS was selected for the running buffer.The detection wavelength was set at 195 nm.The separation voltage was 15 kV and the column temperature was maintained at 20℃.The sample was injected at 50 mbar for 5 s.RESULTS The calibration curves of the six preservatives in Maxing Zhike syrup showed good linearity(r≥0.9993).RSDs of precision and stability test were<2.0%.The average recoveries of the method were between 98.7%-101.2%(n=9).No sorbic acid and parabens were detected in 10 batches of samples from 5 enterprises.The benzoic acid content of samples from 5 enterprises was consistent with the prescription.CONCLUSION The method is suitable for the detection of preservative in Maxing Zhike syrup.The obtained results are valuable for its manufacturing process and quality control.
关 键 词:胶束电动毛细管电泳 麻杏止咳糖浆 苯甲酸 山梨酸 苯甲酸甲酯类
分 类 号:R917[医药卫生—药物分析学]
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