UHPLC-MS/MS法测定复方夏天无片中盐酸麻黄碱和盐酸伪麻黄碱含量  

Determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Compound Xiatianwu tablet by UHPLC-MS/MS

作　　者：陈伟康 黄东 刘德鸿 刘艳梅 陈希 CHEN Wei-kang;HUANG Dong;LIU De-hong;LIU Yan-mei;CHEN Xi(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院国家药品监督管理局中成药质量评价重点实验室江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《化学工程师》2022年第5期30-32,90,共4页Chemical Engineer

摘　　要：目的 建立超高效液相串联质谱法测定复方夏天无片中盐酸麻黄碱和盐酸伪麻黄碱含量的方法。方法 采用 Themo Scientific(150mm×2mm,3μ)色谱柱,以乙腈- 0.1%甲酸为流动相,流速 0.4mL·min^(-1)梯度洗脱。质谱采用正离子多反应监测模式,母离子 - 子离子对为 m/z 166.2→148.3。结果 盐酸麻黄碱和盐酸伪麻黄碱分别在浓度 51.12~1022.43、58.72~1174.4ng·m L^(-1)范围内线性关系良好,相关系数大于 0.9989,所有的方法学考察均符合要求。结论 该方法灵敏度高,专属性良好,可用于复方夏天无片中盐酸麻黄碱和盐酸伪麻黄碱测定。OBJECTIVE A method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloridein in Compound Xiatianwu tablet was established by UHPLC-MS/MS.METHODS The chromatographic separation was performed on a Themo Scientific C_(18)(150×2mm,3μm)with a mobile phase consisting of acetonitrile and 0.1% formic acid solution at a flow rate of 0.4mL·min^(-1).The MS system was operated in a positive multiple reaction monitoring mode,and the precursor-product ion transition was optimized as m/z 166.2 →148.3.The linear relationship is good for ephedrine hydrochloride and pseudoephedrine hydrochloride between 51.12 ~1022.43 and58.72~1174.4ng·mL^(-1)respectively,r>0.9989.All validation parameters were within the acceptable ranges.CON-CLUSION This method is sensitivity and specificity,and it is suitable for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Compound Xiatianwu tablet.

关 键 词：复方夏天无片 盐酸麻黄碱 盐酸伪麻黄碱 超高效液相串联质谱 

分 类 号：R917[医药卫生—药物分析学]