主成分自身对照法测定重组人胰岛素中杂质B₃₀脱苏氨酸胰岛素的含量

目的: 建立主成分自身对照法测定重组人胰岛素中杂质B₃₀脱苏氨酸胰岛素的含量。方法: 采用外标法,分别测定重组人胰岛素与脱苏氨酸胰岛素的相对保留时间;测定重组人胰岛素和B₃₀脱苏氨酸胰岛素的线性方程,以斜率计算杂质B₃₀脱苏氨酸胰岛素相对于主成分重组人胰岛素的校正因子;通过方法学考察,表明采用主成分自身对照法测定重组人胰岛素中杂质B₃₀脱苏氨酸胰岛素的含量可行。结果: 测得杂质B₃₀脱苏氨酸胰岛素相对于主成分重组人胰岛素的相对保留时间为1.07,校正因子为1.04,可以采用不加校正因子的主成分自身对照法测定其含量。结论: 用主成分自身对照法测定重组人胰岛素中B₃₀脱苏氨酸胰岛素含量的方法可行。

Objective: To establish a self-contrast method for the content determination of impurity des-thr^B30-rh-insulin in recombinant human insulin. Methods: The relative retention time between des-thr^B30-rh-insulin and recombinant human insulin was determined by external standard method.Series of solutions containing des-thr^B30-rh-insulin and recombinant human insulin were prepared for determination of the linear equation,and the slopes of linear equation was used to determine the correction factor between des-thr^B30-rh-insulin and recombinant human insulin.Then, the analytical method was applied to ensure that HPLC method for the determination of des-thr^B30-rh-insulin in recombinant human insulin met the requirement for the intended analytical applications. Results: The relative retention time between des-thr^B30-rh-insulin and recombinant human insulin was 1.07,and the correction factor between des-thr^B30-rh-insulin and recombinant human insulin was 1.04.The calibration factor between substance being examined and impurity was not necessarily used in this method for the content determination. Conclusions: The established self-contrast method in this study was found to be accurate and stable.

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