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.
Keywords: Agilent ZORBAX SB-phenyl; HPLC method; drug product; ethinyl estradiol (EE); ethynodiol diacetate (EDA); method validation.
© 2020 John Wiley & Sons, Ltd.