枸橼酸他莫昔芬在临床上用于治疗乳腺癌,为雌激素调节药。该药有两个异构体,其中只有Z-异构体为活性有效成分,而另一E-异构体为无效杂质,必须控制E-异构体的含量在1％以下才能保证药品质量。同时,该药在放置过程中也会发生分解,检测分解物的量也是必要的。USP和BP中虽已记载了HPLC法,但因为分离度差,不能指示稳定性,碱性移动相对色谱柱的固定相有害等缺点,所以作者建 Tamoxifen citrate is clinically used to treat breast cancer and is an estrogen-modulating drug. The drug has two isomers, of which only the Z-isomer is the active ingredient, while the other E-isomer is an invalid impurity, the content of E-isomer must be controlled below 1% to ensure the quality of the drug . At the same time, the medicine will decompose in the process of placing. It is also necessary to measure the amount of decomposition products. Although the HPLC method has been described in USP and BP, because of poor resolution, can not indicate the stability, the mobile phase relative to the stationary phase of the basic mobile is harmful, so the author built