Development and validation of a quantitative assay for raloxifene by capillary electrophoresis

The migration behavior of raloxifene was investigated by capillary electrophoresis (CE). The influence of different parameters (nature and concentration of the running buffer, pH and applied voltage) on migration time, peak symmetry and efficiency was systematically investigated. A buffer consisting of 20 mM acetate buffer of pH 4.5 was found to provide a very efficient and stable electrophoretic system for the analysis of raloxifene. The optimized method was validated with respect to precision, linearity, limits of detection and quantification, accuracy and robustness. The applicability of the assay was demonstrated by analyzing this drug in human plasma and pharmaceutical preparations. (C) 2004 Elsevier B.V. All rights reserved.