鲑鱼降钙素的两种定量分析方法比较

Two Quantitative Analysis Method was Compared for Preparation or SCT

目的:研究测定降钙素制剂含量的高效液相色谱法,并与酶免法作比较.方法:色谱法采用C_(18)柱(5μm,100mm×4.6mm),流动相为1M氢氧化四甲铵-水-乙腈(8:692:300),进样量200μl;酶免法采用酶免试剂盒,测定同一样品含量.结果:高效液相色谱法在5μg/ml～40μg/ml范围内线性良好,批内和批间误差均小于10%,平均回收率为100.04%;高效液相色谱法和酶免法测定结果相关系数r=0.9931.结论:高效液相色谱法灵敏度不如酶免法,但已能满足测定要求,且精确度高,操作省时,成本低,可以作为精确检测降钙素制剂含量的方法.

Objective: A high-performance liquid chromatographic method is described for the assay ofpreparation of salmon calcitonin and compared with biological assay. Method: The method uses C18 Column (5 m,100 mm × 4. 6 mm), mobile phase 1M tetramethy-lammonium hydroxide-water-acetonitrile (8: 692: 300). The Injection was 200μl and the detector was set UV 210 nm. The results was compared by biological assay in same sample. Results: The linear range of calibration curve was 5-40 μg/ml. The average recovery was 100.4% with RSD<10% (n=6). HPLC and Biological method were correlation coefficient 0.9931. Conclusion: The method has been shown to he selective. precise and rapid, which were applied successfully to the assay of preparation of salmon calcitonion.