Use of a validated stability-indicating HPTLC method to study the degradation of rimonabant

Abstract

Rimonabant (RIM) is a synthetic cannabinoid CB 1 receptor antagonist being developed for the treatment of multiple cardiometabolic risk factors, including abdominal obesity and smoking. This paper describes development and subsequent validation, in accordance with International Conference on Harmonization (ICH) guidelines, of a simple, sensitive, selective, precise, and stability-indicating HPTLC method for analysis of rimonabant. Silica gel plates were used with methanol-water 7:3 ( v/v ) as mobile phase. Densitometry was performed at 250 nm. Compact bands were obtained at R F 0.71 ± 0.02. Linear regression analysis of calibration data revealed good linear relationship with r 2 = 0.9985 in the working concentration range of 100–800 ng per band. The method was validated for precision, accuracy, ruggedness, robustness, specificity and recovery. The drug was subjected to acidic and alkaline hydrolysis, oxidation, dry heat, UV irradiation, and photodegradation in daylight. The peaks of degradation products w...