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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 establish a method for the determination of the main drug content in Eutratii injection. Methods: Using high performance liquid chromatography. The chromatographic column was a Phenomenex Nucleosil C8 column with a mobile phase of 0.1% trifluoroacetic acid-0.07% trifluoroacetic acid in acetonitrile (gradient elution) at a flow rate of 1.0 ml / min. The column temperature was 40 ° C. and the detection wavelength was 220 nm. The amount is 200 μl. Results: The linear regression of eosin for calcitonin in the range of 1.0-2.5 U was obtained (r = 0.9990). The RSD of precision and repeatability test were both less than 1.4% and the average recovery was 103.4 %, RSD = 0.96% (n = 9). Conclusion: The method is simple, sensitive, accurate and reliable, and can be used to determine the content of the main drug in Eca Calcium Injection.