Abstract

RODRIGUEZ CHANFRAU, Jorge E  and  LOPEZ ARMAS, Marilyn. Validation of an analysis method to determine raloxifene in a Cuban formulation. Rev Cubana Farm [online]. 2014, vol.48, n.1, pp.13-22. ISSN 0034-7515.

Introduction: raloxifene is a selective estrogen receptor modulator from the benzothiophene family. The results of several large clinical trials have shown that raloxifene reduces the rate of bone loss in the dorsal spine and may increase bone mass at certain sites. Objective: to validate an analytical method for determination of raloxifene in a Cuban formulation. Methods: a high performance liquid chromatography analytical method has been developed for the estimation of raloxifene in Cuban pharmaceutical dosage form. In this method, RP 18 Lichrospher^® 100 column with mobile phase consisting of methanol, de-ionized water and trietanolamine (ratio of 70:30:0.1) and 286 nm wavelength ultraviolet detector were used. The mobile phase flow was 1.5 mL/min and the injected volume reached 20 mL Results: the results showed that the suggested method for raloxifene quantitation was specific, accurate, precise and linear. Conclusions: under the studied conditions the analytic procedures can be applied for routine quality control analysis of raloxifene in pharmaceutical dosage form.

Keywords : raloxifene; analytical method; high performance liquid chromatography; validation.

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