A Simple Colorimetric Method for the Determination of Raloxifene Hydrochloride in Pharmaceuticals Using Modified Romini's Reagent

Abstract

An analytical method has been developed based on a colorimetric assay for the estimation of raloxifene hydrochloride, followed by validation of the optimized method by using the ICH guidelines. The new method, aromatic ring derivatization technique, is based on a coupling reaction using modified Romini's reagent in which sodium nitroprusside is used as a chromogenic derivatizing reagent. Raloxifene contains a phenolic hydroxyl group, containing reactive hydrogen. This reactive proton reacts with sodium nitroprusside and reduces it to sodium meta-hydrogen ferrocyano nitrate, which is a colored product. Optimization studies revealed that the coupling reaction was very rapid and completed in less than 1 minute. A 1: 1 drug-to-reagent stoichiometric ratio was obtained for the azo dye formed. The azo adduct formed exhibits a bathochromic shift with absorption maximum max at 440 nm, which was selected as the analytical wavelength. The drug seems to be linear, which was established via the regression analysis from 20 to 120μg/ml. LOD and LOQ of the developed method were found to be 1.807μg/ml and 5.47μg/ml, respectively. Interday and intraday precision was studied, and %RSD was less than 2. Since the stability of the drug and the reagent was found to be predominantly massive, this method can be used for the formulation of raloxifene hydrochloride. The method can be extended for the routine assay of raloxifene formulations.