Rangan M. et.al., Development and validation of a rapid ultra-high performance liquid chromatography method for the assay of benzalkonium chloride using a quality-by-design approach. Journal of Chromatography A, Volume 1413, September (2015).
Abstract from the original article:
A rapid robust reversed-phase UHPLC method has been developed for the analysis of total benzalkonium chloride in preserved drug formulation. A systematic Quality-by-Design (QbD) method development approach using commercial, off the shelf software (Fusion AE®) has been used to optimize the column, mobile phases, gradient time, and other HPLC conditions. Total benzalkonium chloride analysis involves simple sample preparation. The method uses gradient elution from an ACE Excel 2 C18-AR column (50 mm × 2.1 mm, 2.0 μm particle size), ammonium phosphate buffer (pH 3.3; 10 mM) as aqueous mobile phase and methanol/acetonitrile (85/15, v/v) as the organic mobile phase with UV detection at 214 nm. Using these conditions, major homologs of the benzalkonium chloride (C12 and C14) have been separated in less than 2.0 min. The validation results confirmed that the method is precise, accurate and linear at concentrations ranging from 0.025 mg/mL to 0.075 mg/mL for total benzalkonium chloride. The recoveries ranged from 99% to 103% at concentrations from 0.025 mg/mL to 0.075 mg/mL for total benzalkonium chloride. The validation results also confirmed the robustness of the method as predicted by Fusion AE®.
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