高效液相色谱法考察复方头孢氨苄胶囊的溶出度

Determination of dissolution of compound cephalexin capsule by HPLC

采用反相高效液相色谱外标法 ,对复方头孢氨苄胶囊溶出度进行考察。方法 :采用转蓝法 ,以 4%乙酸溶液为溶剂 ,转速为10 0r/min ,时间为 45min。色谱条件 :C18反相色谱柱为固定相 ,V(水 )∶V(甲醇 )∶V(3 .86%乙酸钠溶液 )∶V(4%乙酸溶液 ) =742 :2 40 :15 :3为流动相 ,流速为 1.2mL/min ,紫外检测波长为 2 5 4nm ,在此条件下头孢氨苄和甲氧苄啶两组分能很好地分离。本法的线性范围分别是头孢氨苄为 :2 7.6～ 2 76μg/mL ,甲氧苄啶为 :5 .5 6～ 5 5 .6μg/mL ,平均回收率为头孢氨苄 :99.3 2 % ,RSD =0 .78% ;甲氧苄啶 :10 0 .1% ,RSD =0 .5 7%。

A reversed phase HPLC (RP HPLC) method for the determination of the dissolution of compound cephalexin capsule was developed. A basket stirring technique was applied, with 4% acetic acid solution as dissolvent, at speed of 100 r/min for 45 min . A C 18 reversed phase column was used as fixed phase and water methanol 3.86% sodium acetate 40% acetic acid (742∶240∶15∶3) as mobile phase. The flow rate was 1.2 ml/min and UV detection was performed at 254 nm. Cephalexin and Trimethoprim (TMP) could be separated in this condition. The linear ranges were 27.6～276 μg/mL for Cephalexin and 5.56～55.6 μg/mL for TMP. The recovery and RSD were 99.32% and 0.78% for Cephalaxin and 100.1% and 0.57% for TMP respectively.