超高效液相色谱法测定德谷胰岛素含量

Assay Determination of Insulin Degludec by UPLC

目的:建立测定德谷胰岛素含量的超高效液相色谱法。方法:色谱柱为Waters C18(2.1 mm×100 mm,1.7μm),流动相A为0.1 mol/L硫酸钠溶液(pH值5.7)-乙腈(体积比90∶10),流动相B为50%乙腈,梯度洗脱;流速为0.25 mL/min,检测波长为214 nm,柱温为40℃,进样量为2μL。结果:德谷胰岛素浓度在0.1~1.2 mg/mL时与峰面积线性关系良好,精密度、稳定性、重复性、耐用性试验的RSD均小于1%,平均回收率为100.10%,回收率RSD为0.63%(n=9)。结论:该方法专属性强,精密度、稳定性、重复性、耐用性好,可用于德谷胰岛素的含量测定。

Objective:To establish a UPLC method for the assay determination of insulin Degludec.Methods:The chromatographic column is Waters C18 column(2.1 mm×100 mm,1.7μm),the mobile phase A is 0.1 mol/L Na2SO4 solution-acetonitrile(the volum ratio is 90∶10),pH is adjusted to 5.7,the mobile phase B is 50%acetonitrile with gradient elution,the flow rate is 0.25 mL/min,the detection wavelength is 214 nm,the column temperature is 40℃,and the sample size is 2μL.Results:The insulin Degludec show a good linear relationship in the range of 0.1~1.2 mg/mL.The RSD of precision,stability,repeatability and robustness tests are all less than 1%,the average recovery rate is 100.10%,and RSD of recovery rate is 0.63%(n=9).Conclusion:The method is specific,accurate,stable,reproducible and robust,which can be used for the assay determination of insulin Degludec.