HPLC法测定乙肝扶正胶囊中盐酸麻黄碱和盐酸伪麻黄碱的含量  

Simultaneous determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Yigan Fuzheng Capsules by HPLC

作　　者：钟建青 傅超 袁航 殷士宁 尹丽华 单秀明 张春辉 吴爱英 ZHONG Jianqing;FU Chao;YUAN Hang;YIN Shining;YIN Lihua;SHAN Xiuming;ZHANG Chunhui;WU Aiying(Qingdao Institute for Food and Drug Control,Qingdao 266071,China)

机构地区：[1]青岛市食品药品检验研究院

出　　处：《中国药品标准》2019年第6期515-520,共6页Drug Standards of China

摘　　要：目的:建立测定乙肝扶正胶囊中盐酸麻黄碱和盐酸伪麻黄碱的含量的高效液相色谱法,制定含量参考限度。方法:考察了三种不同的色谱柱,分别为色谱柱1:Agilent ZORBAX SB-C18(4.6 mm×250 mm,5.0μm),柱2:Agilent Eclipse Plus C18(4.6 mm×250 mm,5.0μm),柱3:SHARPSIL-T C18(4.6 mm×250 mm,5μm);流动相:乙腈-0.2%磷酸(4∶96);检测波长:206 nm,流速1.0 mL·min^-1,柱温:30℃。结果:盐酸麻黄碱在13~131μg·mL^-1的范围内呈良好的线性关系,回归方程为Y=22.6143X+3.2897,r为1.0000,方法平均回收率103.7%(RSD3.16%,n=6),84批样品的盐酸麻黄碱含量在0.05~0.28 mg·g-1之间;盐酸伪麻黄碱在9~87μg·mL^-1的范围内呈良好的线性关系,回归方程为Y=23.3020X+1.1772,r为1.0000,方法平均回收率95.4%(RSD1.11%,n=6),84批样品的盐酸伪麻黄碱含量在0.02~0.12 mg·g-1之间。结论:该方法简便,快速,准确,可用于该制剂中盐酸麻黄碱和盐酸伪麻黄碱的含量测定,测定了84批次样品的数据,拟定了含量参考限度值。Objective:To establish an HPLC method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Yigan Fuzheng capsules and set the contents limits.Methods:3 kinds of chromatographic columns of Agilent ZORBAX SB-C18(4.6 mm×250 mm,5.0μm),Agilent Eclipse Plus C18(4.6 mm×250 mm,5.0μm)and SHARPSIL-T C18(4.6 mm×250 mm,5μm)were investigated.The mobile phase was acetonitrile and 0.2%phosphoric acid solution(4∶96).The flow rate was 1.0 mL·min^-1,the detection wavelength was 206 nm,and the column temperature was 30℃.Results:The linear range of ephedrine hydrochloride fell into 13-131μg·mL^-1 with the calibration equation as Y=22.6143X+3.2897(r=1.0000).The average recovery was 103.7%with RSD as 3.16%(n=6).The contents of ephedrine hydrochloride in 84 batches of samples were 0.05-0.28 mg·g-1.The linear range of pseudoephedrine hydrochloride fell into 9-87μg·mL^-1 with the calibration equation as Y=23.3020X+1.1772(r=1.0000).The average recovery was 95.4%with RSD as 1.11%(n=6).The contents of pseudoephedrine hydrochloride in 84 batches of samples were 0.02-0.12 mg·g-1.Conclusion:The established method is simple,fast and accurate.It can be used for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Yigan Fuzheng capsules.84 batches of samples are determined and the contents limits are proposed for reference.

关 键 词：乙肝扶正胶囊 盐酸麻黄碱 盐酸伪麻黄碱 高效液相色谱法 含量测定 

分 类 号：R921.2[医药卫生—药学]