Objectives: To establish the HPLC and GC fingerprints of conjugated estrogens (CE) material for the quality control of conjugated estrogens material; To evaluate the pharmaceutical equivalence of conjugated estrogens material by LC-MS method with qualitative analysis.
目的:建立结合雌激素原料药的HPLC和GC指纹图谱,评价结合雌激素原料药的内在质量;用LC-MS法对结合雌激素进行定性分析,对结合雌激素(以下简称为CE)原料药进行药物等效性评价(Pharmaceutical equivalance)。
