HPLC法同时测定白斑膏中4种成分的含量

目的建立白斑膏中 4种成分含量测定方法。方法采用HPLC法测定白斑膏中克霉唑、氢化可的松、己烯雌酚、马来酸氯苯那敏含量。选用DiamonsilC18柱 (1 5 0mm× 4 6mm ,5 μm) ,流动相为甲醇 水 乙腈 三乙胺 (体积比 65∶2 5∶1 0∶0 2 ) ,流速 1 0mL·min-1,检测波长 2 60nm。结果该方法不受处方中基质成分干扰 ,克霉唑在 0 5 4～ 1 2 6g·L-1、氢化可的松在 3 0 0～ 70 0mg·L-1、己烯雌酚在 0 9～ 2 1mg·L-1、马来酸氯苯那敏在 5 4～ 1 2 6mg·L-1内线性关系良好 (rclotrimazole =0 9999,rhydrocortisone=0 9996,rdiethylstilbestrol=0 9998,rchlorphenamine=0 9996) ,平均加样回收率 :克霉唑 99 5 %、氢化可的松 99 6%、己烯雌酚 99 2 %、马来酸氯苯那敏 1 0 0 1 %。RSD分别为 1 1 %、1 3 %、0 89%、1 5 % (n =5 )。结论该方法可以控制白斑膏的质量

Simultaneous determination of the contents of the four components in the Baiban Cream by HPLC

Objective To develop a method for the determination of the contents of the four components in the Baiban Cream. Methods Clotrimazole, hydrocortisone, diethylstilbestrol, chlorphenamine maleate in the Baiban Cream were determined by high-performance liquid chromatography with the detection wavelength at 260 nm and were eluted with methanol-water-acetonirile-triethylamine (65∶25∶10∶0.2 ) on C 18 column.Results The calibration curve was liner within the range of 0.54～1.26 g·L -1 for clotrimazole ( r= 0.999 9),30.0～ 70.0 mg·L -1 for hydrocortisone (r= 0.999 6),0.9～ 2.1 mg·L -1 for diethylstilbestrol (r= 0.999 8) and 5.4～ 12.6 mg·L -1 for chlorphenamine maleate(r= 0.999 6).The average recoveries of the added components in samples of clotrimazole, hydrocortisone, diethylstilbestrol and chlorphenamine maleate were 99.5%,99.6%,99.2%,100.1% respectively. RSD were 1.1%,1.3%,0.89%,1.5% respectively.Conclusion The method can be used for the quality control of the Cream.