法莫替丁注射液中主成分含量和有关物质测定方法改进  

Improvement of the Method for Content Determination of Main Component and Related Substances in Famotidine Injection

作　　者：苏彦斌[1] 张凤荣 苏彦文[1] 

机构地区：[1]吉林化工学院,吉林吉林132022 [2]吉林省食品药品检验所,长春130033

出　　处：《中国药房》2013年第32期3058-3060,共3页China Pharmacy

摘　　要：目的:建立测定法莫替丁注射液中主成分含量和有关物质的方法。方法:采用高效液相色谱法。色谱柱为Wasters C18柱,流动相为醋酸盐缓冲液-乙腈(93:7,V/V),流速为1.1ml/min,检测波长为267nm,柱温为30℃,进样量为20μl。结果:法莫替丁检测质量浓度在0.02～0.20μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.9999);精密度、稳定性、重复性试验的RSD均≤0.54%;平均加样回收率为99.92%,RSD=1.16%(n=9);法莫替丁的最低检测限为0.5ng,定量限为2ng,主成分法莫替丁与杂质分离度良好。结论:该方法专属性强、准确度高、重复性好,可作为法莫替丁注射液的质量控制方法。OBJECTIVE：To establish the method for the content determination of main components and related substances in Famotidine injection.METHODS：HPLC method was adopted.The determination was performed on Wasters C18 column with mobile phases consisted of acetate buffer-acetonitrile（93：7,V/V）at the flow rate of 1.1 ml/min.The detection wavelength was set at 267 nm,and the column temperature was 30 ℃.The sample size was 20 μl.RESULTS：The linear range of famotidine were 0.02-0.20 μg/ml（r=0.999 9）with an average recovery of 99.92%（RSD=1.16 %,n=9）.The RSDs of precision,stability and repeatability tests were all lower than 0.54%.The lowest limit of detection was 0.5 ng,and the limit of quantity was 2 ng.The main component famotidine and impurity substances were well separated.CONCLUSIONS：The method is specific,accurate and reproducible for quality control for Famotidine injection.

关 键 词：法莫替丁 注射液 有关物质 含量测定 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]