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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。
Select the optimal HPLC chromatographic conditions, gradient elution separation and determination of the original drug and injection salmon calcitonin content. The analytical column was Vydac 2 1 8TP54C18 (4.6 × 250 mm, 30 000, 5 μm). The mobile phase consisted of 0,05 mol L sodium phosphate monobasic buffer solution (pH = 3.0) Liquid + acetonitrile (2: 3). Gradient elution: B solution increased from 45% to 70% in 20 min. Detection wavelength of 2 1 5nm. The precision, linearity and recovery of the method were all good. Compared with the bioassay, the method was simple, rapid and economical, and the results were satisfactory. The established method was used to investigate the stability of the original drug and its injection.