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Turkish Journal of Chemistry

DOI

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Abstract

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

First Page

543

Last Page

552

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