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

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 x 0.25 mm x 0.25 m, Agilent Technologies); injector temperature 250 degrees C; split ratio 40:1; sample volume 0.5 L; He carrier gas; constant pressure mode; flow rate 1.4 mL/min; furnace temperature profile: initial 160 degrees C (constant for 3 min), ramp at 40 degrees C/min to 200 degrees C (constant for 0.6 min), ramp at 40 degrees C/min to 220 degrees C; analysis time 7.133 min; and detector temperature 250 degrees 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.