Development and Validation of a Column High-Performance Liquid Chromatographic Method for Determination of Sibutramine in Capsules
Abstract The development and validation of a reversed-phase liquid chromatographic (LC) method for the determination of sibutramine hydrochloride monohydrate in capsules is described. An isocratic LC analysis was performed on a reversed-phase RP-18 column (250 4.6 mm id, 5 m particle size). The mobile phase consisted of methanolwatertriethylamine (80 + 20 + 0.5, v/v/v), with pH adjusted to 5.65 with 85 phosphoric acid, and was pumped at a constant flow rate of 1.0 mL/min. Measurements were made at a wavelength of 223 nm. The calibration curve was linear over the range of 1540 g/mL [correlation coefficient (r2) = 0.9998]. The relative standard deviation (RSD) value for intraday precision was 0.84. The RSD value for interday precision was 0.90. Recoveries ranged from 99.64 to 100.66. No interferences from the excipients were observed. Because of its simplicity and accuracy, the method is suitable for routine quality control analysis of sibutramine in capsules.