摘要
目的 建立高效液相色谱法同时测定胰岛素吸入粉雾剂中胰岛素含量和有关物质含量。方法 采用梯度洗脱法 ,初始流动相为A(0 1%三氟乙酸 乙腈 ,70∶30 ) ,在 30min内梯度改变为B(0 1%三氟乙酸 乙腈 ,6 0∶4 0 ) ,流速 2 0mL·min- 1 ,柱温 30℃ ,检测波长 2 80nm ,进样量 2 0 μL。 结果 方法专属性强 ,含量测定精密度试验 (RSD)为1 0 8% ,溶液在 12h稳定 ,回收率试验表明胰岛素实测量接近加入量。
AIM To determine insulin and its related substances in insulin powder for inhalation by reversed phase high performance liquid chromatography method. METHODS The initial mobile phase was solution A (0 1% trifluoroacetic acid acetonitril 70∶30) and changed to solution B (0 1% trifluoroacetic acid acetonitril 60∶40) in 30 minutes. The flow rate was 2 0 mL·min -1 , the column temperature was 30℃, the wave length was 280 nm, the injected volume was 20 μL. RESULTS Insulin was well separated from other peaks induced in different conditions. There was good linear relationship between the amount of insulin and its peak area, the RSD was 1 1%, the insulin solution for determination was stable in 12 hours, and the quantity detected was near the added. CONCLUSION The method is simple and accurate to detect insulin and its related substances in insulin and its preparations.
出处
《药学学报》
CAS
CSCD
北大核心
2002年第2期131-133,共3页
Acta Pharmaceutica Sinica
基金
江苏省新药创制基金项目 (990 3 0 2 2 )
