中国药业2023，Vol.32Issue(23)：7-12,6.DOI:10.3969/j.issn.1006-4931.2023.23.002
复方氨酚烷胺片(胶囊)中主成分含量均匀度测定
Determination of Content Uniformity of Main Components in Compound Paracetamol and Amantadine Hydrochloride Tablets(Capsules)
摘要
Abstract
Objective To establish a high-performance liquid chromatography(HPLC)method for determining the content uniformity of caffeine and chlorpheniramine maleate in Compound Paracetamol and Amantadine Tablets(Capsules),and to investigate its effect on the weight difference.Methods The chromatographic column was YMC-C18 column(250 mm × 4.6 mm,5 μm),the mobile phase was 0.1 mol/L phosphate buffer(pH 3.0)-methanol(60∶40,V/V),the flow rate was 1.0 mL/min,the detection wavelengths were 275 nm(acetaminophen)and 225 nm(caffeine,chlorphenamine maleate),the column temperature was 35 ℃,and injection volumes were 5 μL(acetaminophen)and 20 μL(caffeine,chlorpheniramine maleate).The relationship between the weight difference and the content uniformity of main components of products from three manufacturers with higher S-value was investigated.Results Among the 106 batches of samples from 44 manufacturers of Compound Paracetamol and Amantadine Tablets,the qualification rate for the content uniformity of the main components was 91.84％(90/98).Among the 135 batches of samples from 52 manufacturers of Compound Paracetamol and Aminophene Capsules,the qualification rate for the content uniformity of the main components was 94.87％(111/117).The contents of three main components in each tablet of tablet manufacturer C and each granule of capsule manufacturer E were highly consistent with the curve of tablet weight(granule weight),but RSDs of weight difference were 3.31％and 2.25％,respectively.The RSDs of the weight difference for capsule manufacturer K was 1.35％,but only the content of acetaminophen was positively correlated with the weight difference.Conclusion The established method for determining the content uniformity of main components has strong specificity and can provide a reference for the quality control of Compound Paracetamol and Amantadine Tablets(Capsules).It is recommended that the manufacturers mix the main ingredients in a step-by-step order from large to small according to their inventory,in order to improve the mixing uniformity of the product.Meanwhile,control items for the content and content uniformity of caffeine and chlorpheniramine maleate should be added to the quality standards.关键词
复方氨酚烷胺片(胶囊)/对乙酰氨基酚/咖啡因/马来酸氯苯那敏/含量均匀度/生产工艺/逐级混合Key words
Compound Paracetamol and Amantadine Hydrochloride Tablets(Capsules)/acetaminophenol/caffeine/chlorphenamine maleate/content uniformity/production process/mixing step-by-step分类
医药卫生引用本文复制引用
梁静,李超,黄俊,罗立骏,徐登,冯琴,程辉跃..复方氨酚烷胺片(胶囊)中主成分含量均匀度测定[J].中国药业,2023,32(23):7-12,6.基金项目
重庆市技术创新与应用发展专项资助项目[cstc2020jscx-msxmX0237]. （）
