HPLC法测定依降钙素注射液中主药的含量

Content Determination of Main Components in Elcatonin Injection by HPLC

目的:建立测定依降钙素注射液中主药含量的方法。方法:采用高效液相色谱法。色谱柱为Phenomenex NucleosilC8柱,流动相为0.1%三氟乙酸溶液-0.07%三氟乙酸乙腈溶液(梯度洗脱),流速为1.0ml/min,柱温为40℃,检测波长为220nm,进样量为200μl。结果:依降钙素进样量在1.0～2.5U范围内与峰面积积分值呈良好的线性关系(r=0.9990);精密度、重复性试验的RSD均≤1.4%;平均回收率为103.4%,RSD=0.96%(n=9)。结论:该方法简便、灵敏,结果准确、可靠,可用于测定依降钙素注射液中主药的含量。

OBJECTIVE： To develop a method for the determination of main components in Elcatonin injection. METHODS： HPLC method was used. The determination was performed on Phenomenex Nucleosil C8 column with 0.1% TFA-0.07% TAF aceto- nitrile （gradient elution） as mobile phases at the flow rate of 1.0 ml/min. The column temperature was 40 ℃, and the detection wavelength was set at 220 nm. The sample size was 200 μl. RESULTS： The linear range of elcatonin was 1.0-2.5 U（r=0.999 0）. RSDs of precisions and reproducibility tests were lower than and equal to 1.4%.The average recovery of 103.4% （RSD=0.96%, n=9）. CONCLUSIONS： The method is simple, sensitive, accurate and reliable. It can be used for the content determination of main components in Elcatonin injection.