HPLC ANALYSIS OF PHARMACEUTICAL ESTROGENS IN RAW-MATERIALS AND DOSAGEFORMS

The use of HPLC with fluorescence detection (lambda(ex) = 280 nm; lamb da(ex) = 410 or 312 nm) in combination with a postcolumn on line photo chemical derivatization was investigated for the analysis of conjugate d and unconjugated estrogens and their correlated impurities. The colu mn effluents were subjected on-line to W irradiation (254 nm) and the photo induced modifications were useful for the identification of the various estrogens. The proposed HPLC methods were successfully applied to the analysis of commercially available conjugated estrogens (raw m aterials and pharmaceuticals) and estrogen samples. The assay results relative to the pharmaceutical formulations were in agreement with tho se obtained by a reference HPLC method with UV detection (lambda = 250 nm). (C) 1998 Elsevier Science B.V. All rights reserved.