Development and Validation of HPLC Method Using Hydrotropic Mobile Phase for the Estimation of Raloxifene Hydrochloride

Abstract

Hydrotropy is a molecular phenomenon that significantly enhances the solubility of sparingly or poorly water-soluble drugs. In hydrotropy, a hydrotrope (e.g., urea, nicotinamide, sodium benzoate, sodium citrate) is added to a solvent, which serves as the mobile phase in RP-HPLC analysis. This approach reduces the need for harmful and costly organic solvents, making drug analysis more eco-friendly and economical. In this study, a method was developed using 3% sodium benzoate (pH 6.2) as the single mobile phase. The analysis was conducted with a Lichrosphere® RP-18e (C18) (250 × 4.6 mm, 5 µm particle size) column as the stationary phase, with a flow rate of 1 ml/min, and detection at 286 nm using a PDA detector. The retention time was 5.029 minutes, and the method demonstrated linearity over a concentration range of 50–400 µg/ml, with a correlation coefficient of 0.9991. The developed method was validated according to ICH Q2 (R1) guidelines, confirming its suitability for routine analysis of Raloxifene Hydrochloride in bulk and pharmaceutical dosage forms. The objectives of the study were successfully achieved