HPLC测定复方氨酚葡锌片中的有关物质对氨基酚的含量  

Determination of P-aminophenol in Compound Paracetamol and Zinc Gluconate Tablets by HPLC

作　　者：刘凯双 闫研 殷果 王铁杰 LIU Kai-shuang;YAN Yan;YIN Guo;WANG Tie-jie(Shenzhen Institute for Drug Control,Shenzhen 518057,China;Shenzhen Key Laboratory of Drug Quality Standard Research,Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,广东深圳518057 [2]深圳药品质量标准研究重点实验室,广东深圳518057

出　　处：《食品与药品》2022年第3期222-226,共5页Food and Drug

基　　金：国家药典委员会2011年度国家药品标准提高课题(编号:3-42)。

摘　　要：目的采用高效液相色谱法(HPLC)测定复方氨酚葡锌片中的有关物质对氨基酚的含量。方法采用Waters XBridge C_(18)(4.6 mm×250 mm,5μm)色谱柱,0.05 mol/L醋酸铵溶液-甲醇(97:3)为流动相,流速1.0 ml/min,柱温30℃,检测波长230 nm,进样量10μl。结果复方氨酚葡锌片中的主成分与有关物质对氨基酚能完全分离,中药成分板蓝根浸膏粉对对氨基酚检测无影响,对氨基酚在0.8~2.8μg/ml浓度范围内峰面积与浓度呈良好的线性关系,相关系数为0.9998;最低检测限和定量限分别为0.05,0.20μg;两种规格产品的平均加样回收率分别为100.63%,101.37%,RSD分别为1.05%,0.24%(n=9)。结论该方法操作简便、快捷、准确,专属性好,适用于复方氨酚葡锌片中的有关物质对氨基酚的含量测定,有利于质量控制。Objective To establish an HPLC method for determination of relative substance p-aminophenol in Compound Paracetamol and Zinc Gluconate Tablets.Methods Waters XBridge C_(18) column(4.6 mm×250 mm,5μm)was used with the mobile phase of 0.05 mol/L ammonium acetate solution-methanol(97:3).The flow rate was 1.0 ml/min,the detection wavelength was 230 nm and the column temperature was 30℃.The injection volume was 10μl.Results The main constituents and p-aminophenol were separated well.There was no effect on the detection of Isatidis Radix extract powder and p-aminophenol.The calibration curve was linear in the range of 0.8-2.8μg/ml(r=0.9998).The detection limit and quantification limit were 0.05μg and 0.20μg,respectively.The average recoveries of two specifications were 100.63%and 101.37%,and the RSDs were 1.05%and 0.24%(n=9).Conclusion The method is simple,rapid,accurate and suitable for the determination of content of relative substance p-aminophenol in Compound Paracetamol and Zinc Gluconate Tablets,which is conductive to the quality control.

关 键 词：复方氨酚葡锌片 有关物质 对氨基酚 高效液相色谱法 

分 类 号：R927.1[医药卫生—药学]