HPLC法测定己烯雌酚乳膏中己烯雌酚和羟苯乙酯的含量

Simultaneous Determination of Content of Two Components in Diethylstilbestrol Cream by HPLC

目的建立测定己烯雌酚乳膏中己烯雌酚和羟苯乙酯含量的方法。方法采用高效液相色谱法。色谱柱为Diamonsil C18柱（250mm×4．6mm，5μm）；流动相为甲醇-水（75：25）；流速0．8mL／min；检测波长241nm；柱温35℃；进样量20μl。结果该方法不受处方中基质干扰，己烯雌酚的线性范围为10～20μg·ml^-1，r=0．9999（n=5）；平均回收率为99．68％，RSD为0．81％；羟苯乙酯的线性范围为10～20μg·ml^-1，r=0．9999（n=5）；平均回收率为100．1％，RSD为0．72％。结论该法操作简便、灵敏度高，重复性好，可用于己烯雌酚乳膏中己烯雌酚和羟苯乙酯的含量测定。

Aim To establish an HPLC method for simultaneous determination of the two components of Diethylstilbestrol and Ethylparaben in Diethylstilbestrol Cream. Methods The chromatographic conditions were as follows： the column was Diamonsil C18 （250mm × 4.6mm ,5 μm） ; the mobile phase was methyl alcohol-water （75：25 ） ; the UV detection was at 241nm;the flow rate was 0.8ml/min and column temperature was at 35℃. Results The Diethylstilbestrol linear calibration curves were obtained over the range of 10 - 20μg·ml^-1（ r = 0.999 9, n = 5 ）. The average recovery of diethylstilbestrol was 99.68% （ RSD = 0.81% ） in cream. The Ethylparaben linear calibration curves were obtained over the range of 10 - 20μg·ml^-1 （ r = 0. 999 9, n = 5 ）. The average recovery of diethylstilbestrol was 100.1% （ RSD = 0.72% ）in cream. Conclusion The method is simple and accurate,with high sensitivity and good repeatability in the control of Diethylstilbestrol Cream.