Turkish Journal of Chemistry, Vol.30, No.5, 543-552, 2006
Performance comparison between monolithic C18 and conventional C18 particle-packed columns in the liquid chromatographic determination of propranolol HCl
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.
Keywords:monolithic columns;Chromolith Performance;propranolol hydrochloride;performance;validation;degradation products;method transfer;batch reproducibility