HPLC法测定注射用法莫替丁的有关物质

HPLC determination of relative substances in famotidine for injection

目的:用高效液相色谱法测定注射用法莫替丁中有关物质的含量。方法:采用Diamonsil C 18色谱柱;以0.01mol.L-1庚烷磺酸钠溶液-乙腈-甲醇(25∶6∶1),用冰醋酸调节pH至3.9;流速:1.0ml/min,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为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0.02 ng.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 relative substances in famotidine for injection was established. Methods： Diamonsil C 18 column; the mobile phases consisted of 0.01 mol ？ 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, detecting wavelength was267nm. Results： The linear range of relative substances was 106～317 μg？ml-1, γ=0.9712, famotidine And relative substances can be effectively separated, The lowest detection limit of relative substances（ S/N=3 ）were 0.02 ng？ml-1. Conclusion：The method was simple,fast and accurate, It may be adopted for the examination of the impurities of the drug.