HPLC法测定氨酚伪麻那敏分散片中的对氨基酚  

Determination of p-aminophenol in paracetamol,pseudoephedrine hydrochloride and chlorphenamine maleate dispersible tablets by HPLC

作　　者：江坤 陈颜清 蔡锦雄 庞发根 李玉兰 王铁杰 JIANG Kun;CHEN Yanqing;CAI Jinxiong;PANG Fagen;LI Yulan;WANG Tiejie(Shenzhen Institute for Drug Control,Shenzhen,518057,China)

机构地区：[1]深圳市药品检验研究院,广东深圳518057

出　　处：《中国药品标准》2022年第1期24-28,共5页Drug Standards of China

基　　金：国家药品标准提高研究项目(项目编号:附件3-591)。

摘　　要：目的:建立高效液相色谱法测定氨酚伪麻那敏分散片中对氨基酚的含量。方法:采用ZORBAX E-clipse XDB-C_(18)(4.6 mm×250 mm,5μm);流动相为磷酸盐缓冲液-甲醇(95∶5);流速1.0 mL·min^(-1);检测波长230 nm;柱温30℃;进样量10μL。结果:对氨基酚和相邻色谱峰分离度良好,对氨基酚定量限为0.911 4ng,检测限为0.375 9 ng,在0.102 9~30.87μg·mL^(-1)浓度范围内线性良好(r=1.000),回收率为96.8%,RSD为0.4%(n=9)。结论:该方法准确、灵敏,可用于氨酚伪麻那敏分散片中对氨基酚的含量测定。Objective:To establish an HPLC method for the determination ofp-aminophenol in pseudoephedrine hydrochloride and chlorphenamine maleate dispersible tablets.Methods:The analysis was performed on a ZORB-AX Eclipse XDB-C_(18) column (4.6 mm×250 mm,5μm) using a mobile phase of phosphate buffer solution-methanol (95∶5) delivered at a flow rate of 1.0 mL·min^(-1).The detection wavelength was set at 230 nm,the column temperature was 30℃,and the injection volume was 10μL.Results:The resolution betweenp-aminophenol and adjacent chromatographic peak was good.The qualification limit and detection limit ofp-aminophenol was 0.9114ng and 0.375 9 ng,respectively.p-aminophenol showed good linearity in the range of 0.102 9-30.87μg·mL^(-1)(r=1.000).The average recovery was 96.8%(RSD=0.4%,n=9).Conclusion:The established method showed good accuracy and sensitivity,which could be used for the determination ofp-aminophenol in pseudoephedrine hydrochloride and chlorphenamine maleate dispersible tablets.

关 键 词：氨酚伪麻那敏分散片 对氨基酚 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]