Development and Validation of a Gas-Chromatographic Method for Quantitative Determination of Phenol in Biologicals

Abstract

A gas-chromatographic method for quantitative determination of phenol in biological drugs was developed. The optimal chromatography conditions were a DB-WAX column (30 m × 0.25 mm × 0.25 μm, Agilent Technologies); injector temperature 250°C; split ratio 40:1; sample volume 0.5 μL; He carrier gas; constant pressure mode; flow rate 1.4 mL/min; furnace temperature profile: initial 160°C (constant for 3 min), ramp at 40°C/min to 200°C (constant for 0.6 min), ramp at 40°C/min to 220°C; analysis time 7.133 min; and detector temperature 250°C. The method was validated. The analytical range of the method was phenol concentrations from 1 to 5 mg/mL. The accuracy and specificity of the method were confirmed. The precision was evaluated. The results allowed this method to be considered an alternative for quantitative determination of phenol in biologicals.