【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 C₁₈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。更多还原

【Abstract】 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 es- tradiol 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 con- centration 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 tot the determination of compound estradiol patch.更多还原