高效液相色谱法测定法莫替丁片溶出度

Determination of the dissolution of famotidine tablets by HPLC

目的 测定法莫替丁片的溶出度。方法 高效液相色谱法 ,以Xterra -C18(3.9× 15 0mm ,5 μm)为色谱柱 ,流动相为庚烷磺酸钠溶液 -乙腈 -甲醇 (2 5∶6∶1) ,流速为 1.0ml/min ;检测波长为 2 5 4nm。结果 本品在 4 0～ 30 0 μg·ml-1范围内线性良好 (r=0 .9998) ,平均回收率为 99.6 5 % ,RSD =0 .4 %。结论 本法可排除辅料对溶出度测定的影响 ,可用于该制剂的质量控制。

Aim An HPLC method for determination of the dissolution of famotidine tablets was described.Method Xterra-C 18(3.9×150mm,5μm) was used as the column,and the mobile phase was sodium heptanesulfonate-Acetonitrile-methanol(25∶6∶1).The flow rate was 1.0ml/min.The wavelength used for detection was 254nm.Results The linear range was 40～300μg·ml -1(r=0.999 8).Average recovery is 99.65%,RSD=0.4%.Conclusion The method can eliminate the infection of accessories,and can be used to control the item.