Development and Validation of Chromatographic Method for Quantitative Analysis of Menopausal Hormones in a Two-Component Preparation


Ucer A., Kas F., DİNÇ E.

CHEMISTRYSELECT, sa.16, 2025 (SCI-Expanded) identifier

  • Yayın Türü: Makale / Tam Makale
  • Basım Tarihi: 2025
  • Doi Numarası: 10.1002/slct.202405405
  • Dergi Adı: CHEMISTRYSELECT
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier
  • Ankara Üniversitesi Adresli: Evet

Özet

The aim of this research article is the development of a novel ultra-performance liquid chromatography (UPLC) procedure for the simultaneous quantitative evaluation of two menopausal hormones, cyproterone acetate (CA) and estradiol valerate (EV), in a marketed dragee formulation by a simple experimental procedure and a short analysis time. A good separation of EV and CA in a chromatogram was obtained by using the Acquity UPLC Waters Symmetry C-18 column system (2.1 mm x 100 mm, 1.7 mu m) and a mobile phase consisting of formic acid buffer and acetonitrile (8:92, v/v) with flow rate of 0.3 mL/min. The retention times of EV and CA were found to be 0.708 and 0.509 min using a detection at 280.0 nm, respectively. The calibration curve was obtained in the concentration range of 10.0-50.0 mu g/mL for EV and 5.0-45.0 mu g/mL for CA. The validity of the proposed UPLC approach was performed by analyzing independent test samples. Then, recovery results and their relative standard deviations were found to be 101.3% and 1.72% for EV and 104.3% and 0.83% for CA, respectively. Consequently, the UPLC method was newly developed and applied, for the first time, to the simultaneous determination of EV and CA in marketed dragee samples.