中国药物评价2025，Vol.42Issue(2)：95-101,7.
HPLC法测定法莫替丁注射剂及片剂中的有关物质
Determination of Related Substances in Famotidine Injection and Famotidine Tablets by HPLC
周雅丽 1曾金亮 1陈小清 2彭素洁 2殷果 1梁智渊 1甘加明2
作者信息
- 1. 深圳市药品检验研究院,广东 深圳 518057
- 2. 广东省药品检验所,广东 广州 510663
- 折叠
摘要
Abstract
Objective:To establish an HPLC method for the detection of related substances in Famotidine Injection and Famotidine Tablets.Methods:The chromatographic column was Kromasil 100-5-C18(4.6 mm ×250 mm,5μm).Mobile phase A was 0.01 mol·L-1 sodium heptane sulfonate(pH was adjusted to 3.5 by glacial acetic acid),mobile phase B was acetonitrile,gradient elution.The flow rate was 1.0 mL·min-1,the column temperature was 30 ℃,the detection wavelength was 266 nm,and the Injection volume was 20 μL.Results:Famotidine peak was well separated from adjacent impurity peaks and between each impurity peaks;The blank excipi-ents did not interfered the detection of impurities.The determination of each impurity was not affected by acid,alkali,light,ultraviolet,high temperature or oxidation destruction;Famotidine and each impurity showed a good linear relationship with the corresponding peak ar-eas within a certain concentration range(r2≥0.999).Detection limit of each component were between 0.003％ and 0.027％.The recov-ery rate of each impurity was between 91.0％ and 103.7％(n=9,RSD＜4.0％).The results of repeatability test,precision test and du-rability test were all well.Nine batches of samples were measured,each impurity was between 0.03％and 1.0％,and the total amount of impurities were between 0.4％ and 2.0％.Conclusion:This method is efficient,selective,and sensitive,and can be used for the deter-mination of related substances in famotidine injection and famotidine tablets.关键词
法莫替丁/有关物质/杂质/高效液相色谱/质量控制Key words
Famotidine/Related substances/Impurities/High-performance liquid chromatography(HPLC)/Quality control分类
药学引用本文复制引用
周雅丽,曾金亮,陈小清,彭素洁,殷果,梁智渊,甘加明..HPLC法测定法莫替丁注射剂及片剂中的有关物质[J].中国药物评价,2025,42(2):95-101,7.
