WEBINAR: Development of simple and rapid UHPLC method for the quantification of 2-phenoxyethanol in vaccines
Presenter: Dr Francesco Marino
Organization: Istituto Superiore di Sanità
Abstract: A new, simple and rapid method for the quantitative determination of the antimicrobial preservative 2-phenoxyethanol, based on reverse phase ultra-high-performance liquid chromatography has been developed. The validation was performed according to the ICH Q2 guideline “Validation of Analytical Procedures”. The desired chromatographic separation was achieved on a C18 column using an isocratic elution, with detection at 270 nm wavelength. The mobile phase consisted of acetonitrile/water (55:45, v/v), pumped at a flow rate of 1 mL/min. The calibration curve is linear (r2 = 0.999) from the concentration of 0.07 mg/mL to 1.1 mg/mL. The percent relative standard deviation for intra- and inter-day precision was <1%. The recovery of 2-phenoxyethanol in vaccines ranged between 96.5 and 100.60%. The limits of detection and quantitation were 1.3 x 10-4 and 2.7 x 10-4 mg/mL, respectively. The method was found to be robust by changing the column working temperature, the percentage of acetonitrile of the mobile phase, and the flow rate.
