氨金黄敏颗粒中对乙酰氨基酚和马来酸氯苯那敏含量测定及含量均匀度方法研究  

Simultaneous determination of content of paracetamol,and content and content uniformity of chlorphenamine maleate in paracetamol,anantadine hydrochloride,artificid Cow-bezar and Chlorphenamine Maleate Granules by HPLC

作　　者：李美芳 陈承贵 蔡锦雄 肖丽和 LI Meifang;CHEN Chenggui;CAI Jinxiong;XIAO Lihe(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,深圳药品质量标准研究重点实验室,深圳518027

出　　处：《中国药品标准》2020年第3期227-233,共7页Drug Standards of China

摘　　要：目的:建立HPLC法同时测定氨金黄敏颗粒中对乙酰氨基酚和马来酸氯苯那敏的含量及马来酸氯苯那敏含量均匀度。方法:色谱柱为Grace Alltima C 18(4.6 mm×250 mm,5μm);以三乙胺溶液(取三乙胺1 mL,加水1000 mL,用磷酸调节pH值至2.6)-乙腈(82∶18)为流动相;检测波长为222 nm(马来酸氯苯那敏)、245 nm(对乙酰氨基酚);进样量为10μL。结果:对乙酰氨基酚在6~125μg·mL^-1、马来酸氯苯那敏在4~103μg·mL^-1范围内与峰面积均呈良好线性关系,分别为r=1.0000(n=5)、r=0.9999(n=5);对乙酰氨基酚的平均回收率为99.6%,RSD%为2.17%(n=9);马来酸氯苯那敏的平均回收率为102.6%,RSD%为1.52%(n=9)。收集的5家生产企业10批样品,测得对乙酰氨基酚标示含量99.4%~103.5%,马来酸氯苯那敏标示含量84.8%~99.7%,马来酸氯苯那敏含量均匀度A+2.2S为6.0~26.0,其中3批A+S大于15.0。结论:本法能同时测定氨金黄敏颗粒中对乙酰氨基酚、马来酸氯苯那敏的含量,以及马来酸氯苯那敏含量均匀度,专属、准确,为氨金黄敏颗粒质量标准的完善和提高提供依据。Objective:To establish an HPLC method for determination of content and content uniformity of paracetamol and chlorphenamine maleate in Paracetamol,Anantadine Hydrochloride,Artificid Cow-bezar and Chlorphenamine Maleate Granules.Methods:The test was performed in Grace Alltima C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of triethylamine solution(adding 1mL of triethylamine in 1000 mL of water and adjusting the pH to 2.6 with phosphoric acid)-acetonitrile(82∶18).The detection wavelengths were 222 nm for chlorphenamine maleate and 245nm paracetamol respectively.The injection volume was 10μL.Results:The linear ranges of paracetamol and chlorphenamine maleate fell into 6-125μg·mL^-1(r=1.0000,n=5)and 4-103μg·mL^-1(r=0.9999,n=5)respectively.The mean recoveries of paracetamol and chlorphenamine maleate were 99.6%and 102.6%with RSDs of 2.17%and 1.52%(n=9)respectively.The test results of 10 batches of samples from 5 manufacturers showed that the labeled contents of paracetamol were 99.4%to 103.5%,and the labeled contents of chlorphenamine maleate were 84.8%to 99.7%.The content uniformity of chlorpheniramine maleate A+2.2S were 6.0-26.0 with A+S of 3 batches were more than 15.0.Conclusion:The established method is specific and accurate.It is suitable for simultaneous determination of paracetamol and chlorphenamine maleate in the compound preparation.It can be referred to for improvement of specification.

关 键 词：氨金黄敏颗粒 对乙酰氨基酚 马来酸氯苯那敏 含量测定 含量均匀度 

分 类 号：R921.2[医药卫生—药学]