法莫替丁注射液有关物质的测定  

Determination of the related substances in Famotidine Injections

作　　者：赵慧[1] 

机构地区：[1]长沙市第四医院,湖南长沙410006

出　　处：《中国当代医药》2010年第3期42-43,共2页China Modern Medicine

摘　　要：目的:建立高效液相色谱法,测定法莫替丁注射液样品的有关物质。方法:色谱柱为Hypersil ODS2(250mm×4.6mm,5μm);流动相为庚烷磺酸钠溶液(取庚烷磺酸钠2.0g,加水900ml溶解后,用冰醋酸调节pH至3.9,加水至1000ml,摇匀)-乙腈-甲醇(26∶7∶1);流速为1.0ml/min;检测波长为254nm;进样量为20μl。结果:有关物质测定法专属性强;10批样品平均有关物质为1.15%,RSD=3.5%(n=10)。结论:方法简便、快速、准确且专属性强,可作为法莫替丁注射液有关物质的质量控制方法。Objective： To establish a HPLC method for the determination of the related substances in Famotidine injections. Methods： HPLC method was used for the determination of the related substances with Hypersil ODS2 column （250×4.6 mm,5 μm）. The mobile phrase was Sodium 1-heptanesulfonate solution（Sodium 1-heptanesulfonate solution 2.0 g was solved with 900 ml water, then adjust pH to 3.9 with acetic acid, diluted to 1 000 ml with water）-acetonitrile-methanol （26∶7∶1） at a flow rate of 1.0 ml/min. The detection wavelength was set at 254 nm, and the injection volume was 20 μl. Results： The HPLC method was specific for the determination of the related substances. The average related substances was 1.15%（RSD 3.5%, n=10） in ten batches of samples. Conclusion： The methods is simple, quick, accurate and specific, It can be used of quality control as Famotidine injections.

关 键 词：法莫替丁注射液 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]