Development and validation of a reversed-phase liquid chromatographic method for analysis of estradiol valerate and medroxyprogesterone acetate in a tablet formulation

A simple and accurate liquid chromatographic method was developed for estim ation of estradiol valerate and medroxyprogesterone acetate in pharmaceutic als. Drugs were chromatographed on a reverse phase C18 column, using a mixt ure (30:70) of ammonium nitrate buffer and acetonitrile and eluants monitor ed at a wavelength of 280 nm. Solution concentrations were measured on a we ight basis to avoid the use of an internal standard. The method was statist ically validated for its linearity, accuracy, precision and selectivity. Du e to its simplicity and accuracy, the authors believe that the method may b e used for routine quality control analysis. It does not require any specif ic sample preparation except the use of a column guard before the analytica l column and suitable prefilter attached to the syringe prior to injection. (C) 1999 Elsevier Science B.V. All rights reserved.