# Quantification of β-Elemene by GC–MS and Preliminary Evaluation of Its Relationship With Antitumor Efficacy in Cancer Patients

## TL;DR

This study developed a method to measure β-elemene in blood and found no link between its levels and cancer treatment effectiveness.

## Contribution

A validated GC–MS method for quantifying β-elemene in human plasma and initial evaluation of its antitumor efficacy.

## Key findings

- The β-elemene quantification method showed high sensitivity and accuracy with a calibration range of 200.0–20,000.0 ng/mL.
- No significant difference in β-elemene exposure levels was found between cancer patients who responded to treatment and those who did not.
- The method was successfully applied to analyze β-elemene in clinical samples from cancer patients.

## Abstract

Objectives: To establish and validate a sensitive and robust gas chromatography–mass spectrometry (GC–MS) method for the quantification of β-elemene in human plasma and assess the correlation between antitumor effect and β-elemene concentration in vivo.

Methods: The chromatographic column was HP-5 ms (30 m × 0.25 mm, 0.25 μm, Agilent, United States of America). The carrier gas was helium (purity > 99.5%). The flow rate was 1.0 mL/min and the total run time was 11.0 min. The plasma sample was pretreated with protein precipitation plus liquid–liquid extraction. Cancer patients were enrolled and their samples were collected for analysis.

Results: Calibration range of β-elemene was 200.0–20,000.0 ng/mL, with correlation coefficients > 0.99. The intra- and interday precision and accuracy were less than 5.8% and within the range of −10.4%–6.6%. The exposure level of β-elemene in the responder group ranged from 278.13 to 11,886.27 ng/mL, with a median of 3568.91 ng/mL, while in the nonresponder group, the range was from 675.92 to 9716.52 ng/mL, with a median of 3351.94 ng/mL. No difference was found in the β-elemene exposure level between the two groups (p > 0.05).

Conclusions: This method was effectively developed, validated, and utilized to quantify β-elemene in cancer patients. The initial findings indicated no significant relationship between therapeutic efficacy and the concentration of β-elemene.