文章摘要
钟建青,傅超,袁航,殷士宁,尹丽华,单秀明,张春辉,吴爱英.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[J].中国药品标准,2019,20(6):515-520
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
投稿时间:2019-03-04  修订日期:2019-11-20
DOI:
中文关键词: 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
英文关键词: Yigan Fuzheng Jiaonang  Ephedrine Hydrochloride  Pseudoephedrine Hydrochloride  HPLC quantitative  analysis
基金项目:2018国家评价性抽验
作者单位E-mail
钟建青 青岛市食品药品检验研究院 qingqing-176@163.com 
傅超 青岛市食品药品检验研究院  
袁航 青岛市食品药品检验研究院  
殷士宁 青岛市食品药品检验研究院  
尹丽华 青岛市食品药品检验研究院  
单秀明 青岛市食品药品检验研究院  
张春辉 青岛市食品药品检验研究院  
吴爱英 青岛市食品药品检验研究院  
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中文摘要:
      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(4.6mm×250mm,5.0μm),柱2:Agilent Eclipse Plus C18(4.6mm×250 mm,5.0μm),柱3:SHARPSIL-T C18(4.6mm×250 mm,5μm);流动相:乙腈-0.2%磷酸(4:96);检测波长:206nm,流速1.0mL?min-1,柱温:30℃。结果:盐酸麻黄碱在13~131 μg?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0.05~0.28mg?g-1之间;盐酸伪麻黄碱在9~87 μg?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。
英文摘要:
      Objective: To establish a method for the determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Compound Yigan Fuzheng Jiaonang by HPLC. Methods: The test was performed in 3 different kinds of chromatographic columns: ①Agilent ZORBAX SB-C18 (4.6mm×250mm,5.0μm), ②Agilent Eclipse Plus C18(4.6mm×250 mm,5.0μm),③SHARPSIL-T C18(4.6mm×250 mm,5μm); with acetonitrile and 0.2% Phosphoric acid solution (4:96) as mobile phase; The flow rate was 1.0 mL?min-1, the detection wavelength was 206nm, and the column temperature was 30℃. Results: The content of Ephedrine Hydrochloride in the range of 13~131 μg?mL-1 had a good linear correlation with peak area,the calibration equation was Y=22.6143X+3.2897 (r=1.0000). The average recovery was 103.7%, with RSD=3.16%(n=6); The contents of Ephedrine Hydrochloride in 84 batches samples was between 0.05-0.28mg?g-1. The content of Pseudoephedrine Hydrochloride in the range of 9-87 μg?mL-1 had a good linear correlation with peak area,the calibration equation was Y=23.3020X+1.1772(r=1.0000). The average recovery was 95.4%, with RSD=1.11%(n=6); The contents of Pseudoephedrine Hydrochloride in 84 batches samples was between 0.02-0.12 mg?g-1. Conclusion: The method is simple, fast and accurate. It can be used for determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Compound Yigan Fuzheng Jiaonang by HPLC. 84 batches samples were determinated and a new content reference limitation was recommended.
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