APPLICATION OF A VALIDATED STABILITY INDICATING HIGH- PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD TO STRESS DEGRADATION STUDIES ON RIMONABANT

Abstract

Rimonabant (RIM) is a synthetic cannabinoid CB1 receptor antagonist being developed for the treatment of multiple cardiometabolic risk factors, and abdominal obesity. The study describes development and subsequent validation of a simple, sensitive, selective, precise and stability indicating high-performance thin layer chromatographic (HPTLC) method for the determination of rimonabant was developed and validated as per ICH guidelines. The mobile phase consisted of acetonitrile and water in the ratio of (5.6: 4.4 v/v). Densitometry of RIM was carried out at 248nm. Compact spots for rimonabant were found at Rf value of 0.72±0.02. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9985 in the working concentration range of 200–800 ng spot-1. Drug was subjected to acid and alkali hydrolysis, oxidation, dry heat, UV and photo degradation. The peaks of degradation products were well resolved from the standard drug with significantly different Rf values. The method was applied for the analysis of marketed formulations of rimonabant and was found to be successful.