高效液相色谱法测定鲑鱼降钙素及其注射液中含量

Determination of Calcitonin and Its Content in Injection by HPLC

选择优化的HPLC色谱条件 ,用梯度洗脱法分离测定原药及注射液中鲑鱼降钙素的含量。以Vydac 2 1 8TP54C1 8柱 (4.6× 2 50mm ,30 0 0A ,5μm )作分析柱 ,流动相∶A液为 0 .0 5mol L磷酸二氢钠缓冲液 (pH =3.0 ) ,B液为A液 +乙腈 (2∶3)。梯度洗脱∶B液在 2 0min内从 45%增加至 70 %。检测波长为 2 1 5nm。方法的精密度、线性关系、回收率均良好 ,和生物测定法相比较 ,本法简便、快速、经济 ,测定结果较为满意。并用建立的方法考察原药及其注射液的稳定性。

A gradient HPLC method was developed for the determination of calcitonin and its content in injection. A Vydac 218T54 C18 column was used and the followed solutions was used as mobile phase: A is 0.05mol/L NaH 2PO 4 (pH3.0), B is A+ acetonitrile (2:3). B solution was changed to 70% from 45% between 0～20 minutes. The UV detector wavelength was 215nm. The precision, linear relationship and recovery were good respectively. Compared with bioassay, the proposed method was faster, more convenient and economical as well as with satisfactory results. The stabilities of Calcitonin and its injection were studied by this method.