摘要
目的:建立盐酸雷尼替丁胶囊溶出度的测定方法。方法:采用HPLC法测定盐酸雷尼替丁胶囊溶出度,色谱柱为JADE PAK C_(18)(4.6 mm×250 mm, 5μm),流动相为0.1%甲酸的乙腈溶液-5 mmol·L^(-1)甲酸铵溶液(10∶90),柱温为35℃,波长为314 nm。结果:雷尼替丁在27.189~203.91μg·mL^(-1)范围内,线性关系良好(r=0.999 8),平均回收率为100.3%,RSD为0.6%(n=9)。测定13家企业158批次样品,其中56批次与参比制剂溶出行为不一致。结论:该方法经方法学验证,可用于盐酸雷尼替丁胶囊的溶出度测定。
Objective:To establish a method for determination of dissolution of ranitidine hydrochloride capsules.Methods:The dissolution of ranitidine hydrochloride capsules was determined by HPLC method in JADE PAK C_(18)(4.6 mm×250 mm,5μm)and acetonitrile solution with mobile phase 0.1%formic acid-5 mmol·L^(-1) ammonium formate solution(10∶90)with a column temperature of 35℃and a wavelength of 314 nm.Results:In the range of 27.189-203.91μg·mL^(-1),ranitidine had a good linear relationship(r=0.9998),an average recovery rate of 100.3%,and an RSD of 0.6%(n=9).158 batches of samples from 13 enterprises were determined,of which 56 batches were inconsistent with the dissolution behavior of the reference preparation.Conclusion:This method is methodologically validated for the determination of dissolution of ranitidine hydrochloride capsules.
作者
陈鸿玉
韩海燕
袁婧
李帅
李钰鑫
李昭
李昌亮
黄钢
CHEN Hongyu;HAN Haiyan;YUAN Jing;LI Shuai;LI Yuxing;LI Zhao;LI Changliang;HUANG Gang(Hunan Institute for Drug Control,Changsha 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha 410001,China;Key Laboratory of pharmaceutical excipients engineering technology of State Drug Administration,Changsha 410001,China;Changsha Institute for Food and Drug Control,Changsha 410036,China;Analytical Applications Center,Shimadzu(China)Co.,Ltd.,Guangzhou 510656,China)
出处
《中国药品标准》
CAS
2023年第5期503-507,共5页
Drug Standards of China
基金
2022年国家药品评价性抽验专项(国药监药管[2022]1号)。
关键词
盐酸雷尼替丁胶囊
高效液相色谱法
溶出度
溶出曲线
参比制剂
转篮法
ranitidine hydrochloride capsules
high performance liquid chromatography
dissolution
dissolution curve
reference preparations
basket rotation method
