HPLC法测定抗过敏滴鼻液各组分含量的质控研究  

Quality Control Research on Content Determination of Each Component in Anti-allergy Drops by HPLC

作　　者：叶吉明[1] 杨景然 刘宇[1] 王竞宇 杜明[1] 冯琳珊[1] 陈文君 YE Jiming;YANG Jingran;LIU Yu;WANG Jinyu;DU Ming;FENG Linshan;CHEN Wenjun(Department of Pharmacy,The First People's Hospital of Yunnan Province,Kunming,Yunnan,China 650032;School of Science,Ningbo University of Technology,Ningbo,Zhejiang,China 315211;Department of Quality,Kunming Sainuo Pharmacy Co.,Ltd.,Kunming,Yunnan,China 650051)

机构地区：[1]云南省第一人民医院药学部,云南昆明650032 [2]宁波工程学院理学院,浙江宁波315211 [3]昆明赛诺制药股份有限公司质量部,云南昆明650051

出　　处：《昆明学院学报》2020年第6期105-109,共5页Journal of Kunming University

摘　　要：为建立抗过敏滴鼻液中3种组分的质量标准,采用高效液相色谱法对其含量进行测定.结果显示,醋酸氢化可的松、盐酸麻黄碱和马来酸氯苯那敏的质量浓度分别在0.250~2.502μg/mL、0.030~0.750μg/mL和0.083~2.076μg/mL范围与峰面积呈良好线性关系,平均加样回收率分别为101.2%、99.2%和101.9%,RSD分别为0.5%、0.4%和1.4%.测定结果符合2015年版《中国药典:四部》中的相关要求.表明该方法专属性强,重现性良好.To establish the quality standards of three components in anti-allergy drops, HPLC is used for content determination. The results show that the mass concentration of hydrocortisone acetate, ephedrine hydrochloride, and hlorpheniramine maleate is in the range of 0.250~2.502 μg/mL, 0.030~0.750 μg/mL and 0.083~2.076 μg/mL respectively and has a good linear relationship with the peak area. The average sample recovery rate is 101.2%, 99.2% and 101.9% respectively;RSD is 0.5%,0.4% and 1.4% respectively. The measurement results are in line with Chinese Pharmacopoeia Part Four 2015 edition, and the method has strong specificity, good reproducibility.

关 键 词：高效液相色谱法 醋酸氢化可的松 盐酸麻黄碱 马来酸氯苯那敏 质量标准 稳定性 

分 类 号：R927[医药卫生—药学]