Performance Comparison between Monolithic C18 and Conventional C18 Particle-Packed Columns in the Liquid Chromatographic Determination of Propranolol HCl

摘要

Monolithic and conventional particle-packed columns were applied for the determination of propranolol hydrochloride in the presence of its 2 main degradation products,3-(1-naphthyloxy)-propane-1,2-diol and 4-isopropyl-1,7-bis-(1-naphthyloxy)-4-azaheptane-2,6-diol.The separations were investigated on monolithic columns at flow rates from 1 to 9 mL/min.Fast and efficient separation was obtained by monolithic columns.The analysis time was decreased by about 5-fold on monolithic columns at a flow rate of 4 mL/min,while maintaining sufficient resolution between propranolol and its degradation products.The method was validated using a set of 3 monolithic columns and compared to a conventional(Superspher)C18 column.The precision for both retention time and peak area was investigated over a wide concentration range(0.002-1 mg/mL)and found to be equal or slightly better on Chromolith Performance compared to the conventional column.Batch to batch reproducibility of the Chromolith Performance columns(n=3)was also calculated.The RSDs % equal 0.66% for retention time and ranged from 0.45% to 1.12% for peak areas.Practical parameters including the pressure drop,plate height,retention time and resolution of monolithic columns were compared to those of a conventional(Superspher)C18 column.The detection and quantitation limits on monolithic columns at both flow rates(1 and 4 mL/min)were 0.012 and 0.04 mu g/mL,compared with 0.061 and 0.2 mu g/mL on the conventional column.The method showed good linearity and recovery and was found to be suitable for the analysis of propranolol hydrochloride formulations.