Abstrato

Stability Indicating HPLC Method for Determination of Rimonabant

Y. Padmavathi, P. Hari Krishna and B. Madhava Reddy

A simple, inexpensive and rapid, stability indica ting isocratic HPLC method has been developed for the quantitative determination of rimonabant, an anti-obesity drug. Degradation studies were performed on the bulk drug by heating to 105°C, exposure to UV light at 254 nm, acid (0.1 N hydrochloric acid), base (0.1 N sodium hydroxide) and aqueous hydrolysis and oxidation with 3.0 % v/v hydrogen peroxide. Considerable degradation was observed under oxidation conditions. Good resolution between the peaks corresponding to impurities produced during synthesis, degradation products and the analyte was achieved on Ace-C18, 150 x 4.0 m.m column using a mobile phase consisting of a mixture of aqueous potassium dihydrogen phosphate and acetonitrile. Validation of th e method was carried out as per ICH requirements.