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 C18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FK（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 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 solutionacetonitrile-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 was106 - 317 μ goml^-1, γ =0.9712, farnotidine And relative substances can be effectively separated, The lowest detection limit of relative substances （S/N=3）were 0.02 ngoml^-1. Conclusion：The method was simple,fast and accurate,h may be adopted for the examination of the impurities of the drug.