头孢氨苄胶囊溶出度测定方法的改进

Improvement of the dissolution determining method of Cefalexin Capsules

目的:改进头孢氨苄胶囊溶出度的测定方法。方法:采用高效液相色谱法测定,对改进方法的精密度、线性关系、回收率进行了考察,同时将改进方法的测定结果与《中国药典》方法进行了比较。结果:头孢氨苄在12.5～250.0μg/ml浓度范围内,峰面积与浓度呈良好的线性关系(r=1.0000),回收率为99.5%,RSD=0.63%(n=6)。结论:改进后的方法更准确、精密、科学,比《中国药典》方法测得结果更满意。

Objective：To improvement the determining method of dissolution of Cefalexin Capsules.Methods：Dissonlution of Cefalexin was determined by HPLC.The accuracy,precision,linearity and recovery of the improved method were investigated.Then,we compared the results obtained from this improved method and the China Pharmacopoeia method.Results：The linear ranges of cefalexin was at 12.5-250.0（r=1.000 0）,and the average recovery was 99.5% with a RSD of 0.63%（n=6）.Conclusion：The improved method is more accurate,precise,scientific.The results is more satisfactory than the results of the China Pharmacopoeia method.