Abstract
ABSTRACT A rapid and simple HPLC method for the determination of gestodene (GTD) and ethinyl estradiol (ETE) in oral contraceptive formulations was developed and validated. Separation of components was achieved on Waters Symmetry Shield Rp‐18 column. Isocratic elution with a mobile phase consisting of methanol and water in a volume percent ratio 80:20 at a flow rate 1.0 mL/min was employed. The components were detected by UV detection at 220 nm. Ciproterone acetate was used as an internal standard (IS). Linear concentration range for GTD was between 0.01 and 0.2 mg/mL and for ETE between 0.005 and 0.08 mg/mL. The detection limit was 2.3 µg/mL for GTD and 0.80 µg/mL for ETE. Mean analytical recovery in determination of GTD and ETE in “Mirelle” (Schering, FRG) tablets was 102.8% for GTD and 101.3% for ETE. Thus, the proposed method is applicable for routine determination of GTD and ETE in contraceptive formulations.
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