Biying Du* Pages 513 - 518 ( 6 )
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.
HPLC method, estradiol valerate tablet, impurities, chromatography, ICH guidelines, quantitative analysis.
Guangzhou Institute for Drug Control, Guangzhou, Guangdong Province