Abstract

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of rimonabant hydrochloride in bulk and tablet dosage forms with greater precision and accuracy. Separation was achieved on C18 column (250X4.6mm i.d., 5µm) in isocratic mode using methanol and water in the ratio 90:10 (v/v) as mobile phase, pumped in to the column  at flow rate of 1 ml/min and the detection of eluent from the column was carried out using variable wavelength detector at 280 nm. The total run time was 10 min and the column was maintained at ambient temperature. The retention times of rimonabant hydrochloride and saquinavir mesylate were 5.760 min and 4.657 min, respectively. The standard curves were linear over the concentration range of 0.2-10 µg/ml and the LOD and LOQ values for rimonabant hydrochloride were 0.0113µg/ml and 0.0345µg/ml, respectively. The percentage recovery was found to be 100 to 100.22 and the % RSD of intraday and inter day precision was found to be 0.572 and 0.549, respectively. The percentage amount of two different marketed tablet formulation of rimonabant hydrochloride was found to be 100.4 and 100.5%. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the routine quality control analysis of rimonabant hydrochloride in bulk and tablet dosage forms.

Key words: Rimonabant hydrochloride, RP-HPLC, saquinavir mesylate, validation, isocratic, ICH guidelines.