Abstract
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. Keywords: HPLC method, estradiol valerate tablet, impurities, chromatography, ICH guidelines, quantitative analysis.
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