HPLC法测定己烯雌酚软膏中己烯雌酚的含量

Determination of Diethylstilbestrol in Compound Diethylstilbestrol Ointment by HPLC

目的：建立测定己烯雌酚软膏中己烯雌酚（DES）含量的高效液相色谱（HPLC）检验方法.方法：采用Nova-PaKC18色谱柱（150mm×4.6mm,5μm）,流动相为甲醇-水（75：25）,流速为1.0mL/min,检测波长为254nm.结果：己烯雌酚在10.08～80.64pg/ml范围内含量与峰面积比呈现良好的线性关系y=2×106×-5433.4（r=0.9999）,平均回收率为98.67%,RSD为0.3%.结论：本法能准确检测已烯雌酚软膏中的己烯雌酚含量,因此可作为已烯雌酚质量控制的有效测量方法.

Objective：A HPLC method was established for the determination of diethylstilbestrol in compound diethylstilbestrol ointment. Methods：A Nova-PaKC 18（150mm×4.6mm,5μm） column was used with the mobile phase of methanol-water（75：25）at the detection wavelength of 254nm.The flow rate was 1.0ml/min.Results：The linear range was（10.08±80.64）μg/ml （r=0.9999）.The average recovery and RSD were 98.67% and 0.3% respectively. Conlusion：The method could be used for the determination of diethylstilbestrol in compound diethylstilbestrol ointment. Therefore it could be used as a effective quality control method for diethylsfilbestrol ointment.