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.
Highlights
The endocannabinoid system controls food intake through both central and peripheral mechanisms, and it may stimulate lipogenesis and fat accumulation (Mazro et al, 2005)
The typical chromatograms of Rimonabant hydrochloride (RMTH) with internal standard in bulk and tablets were shown in Figures 2 and 3
A standard plot of RMTH was constructed by plotting the ratio of the peak area of RMTH to the peak area of the internal standard (Y) against concentration (X)
Summary
The endocannabinoid system controls food intake through both central and peripheral mechanisms, and it may stimulate lipogenesis and fat accumulation (Mazro et al, 2005). Rimonabant hydrochloride (RMTH), Acomplia is a specific inhibitor of the endocannabinoid system (Ducobu et al, 2005) and it is the first of a new class of selective cannabinoid receptor-1 blockers It is a peripherally acting endocannabinoid (CB1) antagonist (Son et al, 2010) that offers novel therapeutic approach to appetite control, weight reduction, smoking cessation and it was an investigational agent for the management of cardiovascular risk factors (Cox, 2005). It reduces the over activity of the endo cannabinoid system, improving lipid and glucose metabolism and regulating food intake and energy balance (Henness et al, 2006).
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