Development of Simultaneous Derivative Spectrophotometric and HPLC Methods for Determination of 17-Beta-Estradiol and Drospirenone in Combined Dosage Form

摘要

Simple, rapid spectrophotometric, and reverse-phase high performance liquid chromatographic methods were developed for the concurrent analysis of 17-beta-estradiol (ESR) and drospirenone (DRS). The spectrophotometric method was based on the determination of first derivative spectra and determined ESR and DRS using the zero-crossing technique at 208 and 282 nm, respectively, in methanol. The linear range was 0.5–32.0 µg·mL⁻¹ for DRS and 0.5–8.0 µg·mL⁻¹ for EST. The limit of detection (LOD) values were 0.14 µg·mL⁻¹ and 0.10 µg·mL⁻¹ and limit of quantification (LOQ) values were 0.42 µg·mL⁻¹ and 0.29 µg·mL⁻¹ for ESR and DRS, respectively. The chromatographic method was based on the separation of both analytes on a C18 column with a mobile phase containing acetonitrile and water (70 : 30, v/v). Detection was performed with a UV-photodiode array detector at 279 nm. The linear range was 0.08–2.5 µg·mL⁻¹ for DRS and 0.23–7.5 µg·mL⁻¹ for EST. LOD values were 0.05 µg·mL⁻¹ and 0.02 µg·mL⁻¹ and LOQ values were 0.15 µg·mL⁻¹ and 0.05 µg·mL⁻¹ for ESR and DRS, respectively. These recommended methods have been applied for the simultaneous determination of ESR and DRS in their tablets.