Simultaneous determination of four hormonal compounds in oral contraceptive tablet formulations by high performance liquid chromatography

A rapid, accurate, and precise HPLC method has been developed for simultaneous determination of four contraceptive hormonal compounds namely ethinylestradiol (EE), drospirenone (DR), gestodene (GS), and levonorgestrel (LV) in oral contraceptive tablet dosage form. The chromatographic separation was achieved on a C18 (150 × 4.6 mm, 5μ) column; the mobile phase consists of acetonitrile: water (50:50, v/v) pumped at a flow rate of 1.0 mL/min; and UV detection was set at 200 nm. The limit of detection was 0.0086 µg/mL for (EE), 0.0397 µg/mL for (GS), 2.80 µg/mL for (DR), and 0.229 µg/mL for (LV), whereas the limit of quantitation (LOQ) was 0.028 µg/mL for (EE), 0.132 µg/mL for (GS), 9.500 µg/mL for (DR), and 0763 µg/mL for (LV), respectively. The correlation coefficient (r) values of the four compounds ranged from 0.99995 to 0.99999. The method was validated as per ICH guidelines and USP 34 for estimation of (EE), (DR), (GS), and (LV) in commercially available tablet dosage form. The validation results were found satisfactory. The proposed method can be useful in quality control of bulk manufacturing and pharmaceutical dosage forms.