Establishment of a Method for Determination of Residual Solvent in Estradiol
The paper established a headspace gas chromatography method and simultaneously determined the residual solvents methanol and ethanol in estradiol.The paper uses a capillary column with 6%cyanopropyl and 94%dimethylpolysiloxane as stationary phases as the chromatographic column,and is detected by a hydrogen flame ionization detector.The methodological validation results indicate that methanol ranges from 2.01 to 20.1 μ.The linear relationship is good within the range of g/mL(r=0.999 8),and ethanol ranges from 2.00 to 24.0 µ.The linear relationship is good within the range of g/mL(r=0.999 8);The recovery rates of methanol are 106.9%,102.2%,and 100.8%,respectively,while the recovery rates of ethanol are 104.3%,103.8%,and 105.9%.This method has strong specificity,high sensitivity,and good accuracy,and can be used for the determination of residual solvents in estradiol.