于1.5mg·mL1（在平均值下浮约20%）,见表3。.PDF

HPLC测定小儿清热止咳颗粒中盐酸麻黄碱和盐酸伪麻黄碱的含量 谢升谷，祝明(浙江省食品药品检验所，杭州 310004) 摘要：目的 建立用反相高效液相色谱法测定小儿清热止咳颗粒中盐酸麻黄碱和盐酸伪麻黄碱含量的方法。方法 采用 ZORBAX SB C 1 18 色谱柱，流动相为0.1%磷酸溶液-乙腈(96 ∶4) ，流速为1.0 mL·min ，紫外检测波长为205 nm 。结果 盐 酸麻黄碱线性范围为4.388~43.88 μg·mL1(r=0. 999 9) ，平均回收率99.7% ，RSD 为2.1%(n=6) 。盐酸伪麻黄碱线性范围为 5.300~53.00 μg·mL1 (r=0. 999 7) ，平均回收率98.5% ，RSD 为2.8%(n=6) 。结论 本法定量准确、重复性好，可作为该制 剂的质量控制方法。 关键词：盐酸麻黄碱；盐酸伪麻黄碱；小儿清热止咳颗粒；高效液相色谱法 中图分类号：R917.101 文献标志码：B 文章编号：1007-7693(2010)03-0255-04 Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride Contents in Xiao’er Qingre Zhike Granules by HPLC XIE Shenggu, ZHU Ming(Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China) ABSTRACT: OBJECTIVE To establish a HPLC method for the determination of ephedrine hydrochloride and 作者简介：谢升谷，男，硕士，药师 Tel: (0571E-mail: xiesgu@163.com 中国现代应用药学2010 年 3 月第 27 卷第 3 期 Chin JMAP, 2010 March, Vol.27 No.3 ·255 · pseudoephedrine hydrochloride contents in Xiao’er Qingre Zhike granules. METHODS Separation was performed on ZORBAX SB C18 column. 0.1% phosphoric acid solution-acetonitrile(96 ∶4) was selected as the mobile phase, flow rate was set at 1.0 mL·min1 and detection wavelength was 205 nm. RESULTS The linear range for ephedrine hydrochloride was 4.388-43.88 μg·mL1(r=0. 999 9), the average recovery of ephedrine hydrochloride was 99.7%, RSD=2.1% (n=6). The linear range for pseudoephedrine hydrochloride was 5.300-53.00 μg·mL1(r=0.999 7), the average recovery of pseudoephedrine hydrochloride was 98.5%, RSD=2.8%(n=6). CONCLUTION The method is accurate and repeatable, and it can be applied to control the quality of this drug. KEY WORDS: ephedrine hydrochloride; pseudo