Department of Quality Operations, Novast Laboratories Ltd, Nantong, Jiangsu Province, China.
Department of Chemical Engineering, Vignan's Foundation for Science, Technology and Research University, Guntur, Andhra Pradesh, India.
Biomed Chromatogr. 2021 May;35(5):e5055. doi: 10.1002/bmc.5055. Epub 2021 Jan 7.
Ethynodiol diacetate (EDA) and ethinyl estradiol (EE) tablets are indicated to prevent pregnancy in women who use oral contraceptives as a contraception method. EDA and EE were separated by reversed-phase HPLC using Agilent ZORBAX SB-Phenyl column, 4.6 mm × 15 cm, 5 μm, using a gradient mixture of acetonitrile and Milli-Q water as mobile phase. The linearity and recovery were found in the range of 0.025-0.25 mg/mL and 0.05-0.18 mg/mL for EDA and 0.001-0.01 mg/mL and 0.002-0.007 mg/mL for EE, respectively. The method is validated according to the regulatory guidelines concerning system suitability, specificity, repeatability, recovery, linearity, robustness, and stability of the sample solution.
醋酸乙孕醇（EDA）和炔雌醇（EE）片被指示用于预防使用口服避孕药作为避孕方法的女性怀孕。使用 Agilent ZORBAX SB-Phenyl 柱，4.6mm×15cm，5μm，通过乙腈和 Milli-Q 水的梯度混合物作为流动相，通过反相高效液相色谱法分离 EDA 和 EE。对于 EDA，线性和回收率分别在 0.025-0.25mg/mL 和 0.05-0.18mg/mL 的范围内，对于 EE，线性和回收率分别在 0.001-0.01mg/mL 和 0.002-0.007mg/mL 的范围内。该方法根据与样品溶液的系统适用性、特异性、重复性、回收率、线性、稳健性和稳定性有关的监管指南进行了验证。
