Development and validation of an analytical method by RP-HPLC for quantification of sibutramine hydrochloride in pharmaceutical capsules

Abstract

Sibutramine is a monoamine re-uptake inhibitor used for the treatment of obesity. In the present study a rapid, sensitive and economical HPLC method was developed and fully validated for analysis of sibutramine HCl in pharmaceutical capsules. HPLC analyses were carried out by using an isocratic elution mode with a mobile phase constituted by sodium phosphate buffer (pH 2.5) and methanol (30 : 70, v/v), flow rate at 1.0 mL min⁻¹, column temperature at 40 °C, UV detection wavelength at 225 nm and 20 µL of injection volume. The validation parameters were in accordance with FDA and ICH specifications, showing accuracy, precision, selectivity, robustness and linearity from 4.5 to 19.5 mg L⁻¹ of sibutramine HCl. The limits of detection and quantification were 0.666 and 2.018 mg L⁻¹, respectively. The validated method is suitable for quality control applications and its advantages over the already existing methods are simplicity and reduced analysis time.