Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2011 Vol: 3 Issue: 3

Development and validation of RP-HPLC method for determination of Raloxifene Hydrochloride from pharmaceutical preparation

Abstract

A simple, efficient, and reproducible method for the determination of raloxifene hydrochloride in tablets has been developed using reverse phase high performance liquid chromatographic method. The elution was done using a mobile phase consisting of buffer and acetonitrile (60:40 v/v) on Symmetry C18, 4.6 x 150mm, 5 mm, XTerra analytical column with flow rate of 0.8 ml/min with detection at 287 nm. An external standard calibration method was employed for quantitation. The elution time was 4.890 min. The linearity range was 10-50 mg/ml for raloxifene hydrochloride. The present method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery), Robustness. The proposed method can be readily utilized for bulk drug and pharmaceutical formulations.