摘要
目的用HPLC法测定注射用法莫替丁中有关物质的含量。方法采用Diamonsil C18色谱柱;以0.01mol.L-1庚烷磺酸钠溶液-乙腈-甲醇（25∶6∶1）为流动相,用冰醋酸调节pH至3.9;流速为1.0mL.min-1,检测波长为267nm。结果有关物质的浓度在106~317μg.mL-1范围内均与峰面积呈良好的线性关系,r=0.9712,法莫替丁与有关物质能有效分离,有关物质的最低检测限（S/N=3）为0.02ng.mL-1。结论此方法简便、快速、准确,可用于该药有关物质的检查。
Objective An HPLC method for the determination of related substances in famotidine for injection was established.Methods Diamonsil C18 column was used;the mobile phases consisted of 0.01mol ·L^-1 sodium heptanesulfonate solution-acetonitrile-methanol（25∶6∶1）（adjust pH to 3.9 with acetic acid）.The flow rate was 1.0mL·min^-1;detecting wavelength was 267nm.Results he linear range of related substances was 106～317μg·mL-1,r=0.9712.Famotidine and related substances can be effectively separated.The lowest detection limit of related substances（S/N=3）was 0.02ng·mL-1.Conclusion The method is simple,fast and accurate.It may be adopted for the examination of the impurities of the drug.
出处
《中国药事》
CAS
2010年第6期576-577,共2页
Chinese Pharmaceutical Affairs
