HPLC法测定复方雌二醇贴片中雌二醇和左炔诺孕酮的含量  

HPLC determination of estradiol and levonorgestrel in compound estradiol patch

作　　者：张凤平[1] 李增和[1] 杜洪光[1] 张恩宏[2] 王丽[2] 王树明[2] 张强[3] 

机构地区：[1]北京化工大学理学院,北京100029 [2]北京康倍得医药技术开发有限公司,北京100089 [3]北京大学药学院,北京100083

出　　处：《药物分析杂志》2008年第1期134-136,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用 HPLC 法测定复方雌二醇贴片中雌二醇和左炔诺孕酮的含量。方法:Symmetry C_(18)色谱柱(150 min×3.9mm,5.0μm),流动相为水-乙腈-甲醇(55:40:5),流速1.0 mL·min^(-1),柱温30℃。雌二醇的检测波长为280nm,在炔诺孕酮的检测波长为240 nm。外标法进行测定。结果:在此色谱条件下,雌二醇、左炔诺孕酮以及辅料能够良好地分离。雌二醇低、中、高3个浓度的平均回收率分别为101.4%,99.2%,98.7%;RSD 分别为1.2%,1.0%,1.0%。左炔诺孕酮低、中、高3个浓度的甲均回收率分别为100.9%,99.6%,98.7%;RSD 分别为0.98%,1.0%,0.89%。结论:该方法简便、准确、可靠,适用于复方雌二醇贴片的定量检测。Objective：To establish a method for the determination of two components in compound estradiol patch by HPLC. Method：A Waters Symmetry column was used. The mobile phase was water- acetonitrile- methanol（55 ： 40： 5） , at a flow rate of 1.0 mL ·min^ -1. The column temperature was 30 ℃. The UV detection wavelength of estradiol and levonorgestrel were 280 nm and 240 nm, respectively. Results：Complete separation was achieved among two compounds under optimun conditions. The average recoveries of low ,middle and high concentration of estradiol were 101.4% ,99.2% ,98.7% （ RSD = 1.2% ,1.0% ,1.0% ） ;The average recoveries of low,middle and high concentration of levonorgestrel were 100. 9% , 99.6%, 98.7% （ RSD = 0. 98% , 1.0% , 0. 89% ）. Conclusion： The method is simple, accurate,reliable and suitable for the determination of compound estradiol patch.

关 键 词：HPLC 贴片 雌二醇 左炔诺孕酮 

分 类 号：R917[医药卫生—药物分析学]