高效液相色谱法测定麻黄止嗽胶囊中盐酸麻黄碱及盐酸伪麻黄碱含量  

Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Mahuangzhisou Capsule by HPLC

作　　者：雷成康 张楠 谢志民 

机构地区：[1]陕西省西安市食品药品检验所,陕西西安710054

出　　处：《中国药业》2014年第17期36-37,共2页China Pharmaceuticals

基　　金：国家药典委员会2010年国家药品标准提高研究课题;项目编号:146

摘　　要：目的：建立测定麻黄止嗽胶囊中盐酸麻黄碱及盐酸伪麻黄碱含量的高效液相色谱法。方法色谱柱为C18柱（250 mm ×4.6 mm，5μm），流动相为乙腈-0.1%磷酸（3：97）梯度洗脱，流速为1.0 mL/min，检测波长210 nm。结果盐酸麻黄碱进样量在0.02~3.12μg范围内、盐酸伪麻黄碱在0.01~1.52μg范围内与峰面积积分值线性关系良好（ r=0.9999）；3种质量浓度盐酸麻黄碱的加样回收率分别为99.26%，99.44%，105.10%，盐酸伪麻黄碱的加样回收率分别为100.48%，102.75%，100.50%。结论该方法简便、准确，可用于控制该制剂的质量。Objective To establish a method for determining the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in Muahuangzhisou Capsule by HPLC. Methods The HPLC assay was carried out on the C18 column （ 250 mm × 4. 60 mm, 5 μm ） , the mobile phase was acetonitine-0. 1% phoshoric acid （ 3 ：97 ） with gradient elution, the flow rate was 1. 0 mL/min, the detection wave-length was set at 210 nm. Results The sample size of ephedrine hydrochloride within the range of 0. 02-3. 12 μg and pseu-doephedrine hydrochloride within the range of 0. 01-1. 52μg showed good linear relation with the peak area （ r=0. 999 9 ） . The recov-ery rates of 3 kinds of concentration of ephedrine hydrochloride sample were 99. 26%, 99. 44% and 105. 10%, and which of pseu-doephedrine hydrochloride sample were 100. 48%, 102. 75% and 100. 50% respectively. Conclusion The method is simple, accurate and suitable to the quality control of Muahuangzhisou Capsule.

关 键 词：麻黄止嗽胶囊 盐酸麻黄碱 盐酸伪麻黄碱 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]