FORCED DEGRADATION STUDIES ON RIMONABANT AND DEVELOPMENT OF A VALIDATED REVERSED PHASE HPLC- UV METHOD FOR DETERMINATION IN PHARMACEUTICAL DOSAGE FORMS

Abstract

Rimonabant (RIM) is a synthetic cannabinoid CB1 receptor antagonist being developed for the treatment of multiple cardiometabolic risk factors, including abdominal obesity and smoking. The study describes development and subsequent validation of a stability indicating reverse phase-HPLC method for assaying rimonabant in pharmaceutical dosage forms. The proposed method utilizes a Phenomenex C18 5µm, 150x4.6mm column, at ambient temperature using a mobile phase composition of water (pH 7.4, 0.05% w/v TEA) and acetonitrile (25:75, v/v). The flow rate was 1ml/min and the analyte monitored at 252nm. Zolpidem tartrate (ZPT) was used as internal standard. The method was found to be linear from 0.5-50µg/ml (r2=0.9997). All the validation parameters were found to be within the acceptance range. The proposed method can be useful in the routine analysis for the determination on rimonabant in pharmaceutical preparations.