RP-HPLC法同时测定避孕贴中炔雌醇与诺孕曲明的含量

Simultaneous Determination of the Content of Ethinylestradiol and Norelgestromin in Hormonal Patches by RP-HPLC

目的：建立同时测定避孕贴中炔雌醇与诺孕曲明含量的方法。方法：采用反相高效液相色谱法。色谱柱为Wonda Cract ODS-2,流动相为甲醇-0.5%磷酸（68∶32,V/V）,流速为1.0 ml/min,检测波长为220 nm,柱温为25℃,进样量为20μl。结果：炔雌醇、诺孕曲明质量浓度分别在0.872~130.8、0.880~132.0μg/ml范围内与各自的峰面积呈良好的线性关系（r=0.999 6、0.999 7）;精密度、重复性、稳定性试验的RSD均≤1.03%;加样回收率分别为101.50%、101.68%,RSD分别为0.99%、0.95%（n=9）。结论：该方法简便、准确,可用于避孕贴中炔雌醇和诺孕曲明的含量测定。

OBJECTIVE： To establish a method for simultaneous determination of ethinylestradiol and norelgestromin in hormonal patches. METHODS： RP-HPLC method was performed on column of WondaCract ODS-2 with mobile phase of metha- nol-0.5% phosphoric acid （68：32, V/V） at a flow rate of 1.0 ml/min, the detection wavelength was 220 nm, the detection temperature was 25 ℃, and sample volume was 20 μl. RESULTS： The linear relationship was 0.872-130.8 μg/ml for ethinylestradiol（r= 0.999 6） and 0.880-132.0 μg/ml for norelgestromin （r=0.999 7） ; RSDs of precision, reproducibility and stability tests were no more than 1.03%, average recoveries were resectively 101.50% （RSD=0.99% ,n=9） and 101.68% （RSD=0.95%, n=9）. CONCLUSIONS： The established method is simple and accurate, and can be used for the content determination of ethinylestradiol and norelgestromin in hormonal patches.