Validation of a sensitive gas chromatographic–mass spectrometric method for the simultaneous determination of β-elemene and β-elemenal in human plasma

Abstract A sensitive gas chromatographic–mass spectrometric assay was described for determination of β-elemene and β-elemenal in human plasma, which has been successfully applied in clinical trial. After liquid–liquid extraction and gas chromatographic separation, the analytes were identified and quantitated. Calibration curves were linear in range from 31.25 to 8000 ng mL −1 and the limit of quantification for both was 31.25 ng mL −1 . Intra- and inter-day precision at three concentrations were 2.3–8.3% with accuracy of −8.5 to 6.1% for elemene and 3.0–9.9% with accuracy of −2.3 to 5.9% for elemenal. The method was validated to be suitable for further pharmacokinetic study.