他莫昔芬中反式异构体的HPLC分离分析
Studies on Separation and Determination of E isomer in Tamoxifen Citrate by HPLC
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摘要: 采用高效液相色谱法,以C18柱、甲醇-水-冰乙酸(79∶21∶0.9)内加0.9mmol/L十二烷基磺酸钠为流动相,280nm紫外检测系统,成功地分离了他莫昔芬顺式和反式异构体,分离效能高,分析时间在20min内,并定量测定他莫昔芬原料药中反式异构体的量。流动相组成经均匀设计优化而得。Abstract: A highly selective HPLC method for the separation and determination of E-isomer impurity in tamoxifen citrate was described. The chromatographic phase is composed of methanol-water-glacial acetic acid(79∶21∶0.9) with 0.9mmol/L sodium dodecyl sulfonate. Mobile phase was optimized using uniform design method. Analytical time is less than 20 min.