长效甾体避孕药RP-HPLC流动相选择性优化与定量分析

采用极角混合设计技术,模拟溶质色谱保留行为的数学模型,用预测优化流动相实验,对溶质色谱保留行为的数学模型进行修正。通过数次预测、迭代、修正数学模型,提高模型的拟合精度,采用多目标优化指标,计算机辅助,寻求三元流动相的最佳组成。首次利用可编程序紫外检测器的时间程序检测功能,提高微量组分的检测灵敏度,成功地解决了两种长效避孕药制剂的定量分析。

OPTIMIZATION OF MOBILE PHASE COMPOSITION FOR RP-HPLC SEPARATION AND DETERMINATION OF LONG ACTING STEROIDAL CONTRACEPTIVES

The optimization of the reversed phase high performance liquid chromatographic separation of six steroids of long acting contraceptives is described. A procedure is used to determine the design space, calculate the coefficients of a seven-term special cubic equation, and modify the model using the optimum experiment. Assisted with the computer, an optimum area could be predicted by overlapping the minimum resolution map with the analysis time map. It is likely that the method described in this paper will provide the basis or the simultaneous optimization of both separation and analysis time and prove to be a useful tool for the optimization of RP-HPLC of known compounds. We firstly utilized the time programming function to improve the detection sensitivities of estrogenic compounds. This method is successfully applied to the analysis of compound megestrol acetate injection and compound hydroxyprogesterone caproate injection. The method is sufficiently simple and rapid yet sensitive and accurate enough for the quality assurance of these types of pharmaceuticals.