Background: Estradiol valerate tablet is used for ovarian dysfunction, menopause, menopausal
syndrome, breast and prostate cancer.
Introduction: HPLC method coupled with photodiode-array detection has been used to develop a simple
and sensitive reversed-phase method for quantitative determination of all possible related impurities
in Estradiol valerate tablet.
Methods: Zorbax eclipse XDB C8(150mmx4.6mm,5µm) column was used. The mobile phase was
gradient prepared from 30:10(v/v) acetonitrile-methanol (component A) and water (component B); the
gradient program (time (min)% B) was 0.01/40, 40.0/40, 40.1/15, 50.0/15, 50.1/40, 55.0/40, 55.1/40,
60.0/40. Eluting compounds were monitored at UV detection (220nm) and fluorescence detection
(Ex:280nm, Em 310nm).
Result: All standard curves obtained exhibited good linear regression (r›0.9996) within the tested range.
All the average recovery rates were in the range of 99.2%-100.8% and RSD were less than 2.0%. The
method was successfully validated according to ICH guidelines acceptance criteria for robustness, selectivity,
linearity, accuracy and precision.
Conclusion: Estradiol valerate was subjected to oxidative, acid, base, thermal and photolytic stress, and
analysis was conducted to determine the amounts of related impurities.