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A sensitive method detecting trace levels of levonorgestrel using LC-HRMS.

Sandy Abujrais1, Matts Olovsson2, Martin Ahnoff3

  • 1Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden.

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|June 20, 2019
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Summary

A new liquid chromatography-high resolution mass spectrometry (LC-HRMS) method accurately quantifies levonorgestrel (LNG) in serum. This sensitive assay detects trace LNG levels, aiding in monitoring intrauterine device (IUD) use and expulsion.

Keywords:
High resolution mass spectrometryIntrauterine deviceLiquid chromatographyLower limit of quantificationSolid phase extraction

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Area of Science:

  • Analytical Chemistry
  • Pharmacokinetics
  • Mass Spectrometry

Background:

  • Levonorgestrel (LNG) is a progestin widely used in hormonal contraceptives.
  • Accurate quantification of LNG in biological matrices is crucial for pharmacokinetic studies and therapeutic drug monitoring.
  • Existing methods may lack the sensitivity or simplicity required for routine clinical application.

Purpose of the Study:

  • To develop and validate a high-resolution mass spectrometry (HRMS) method for quantifying levonorgestrel (LNG) in human serum.
  • To establish a sensitive, rapid, and straightforward analytical technique for trace-level LNG detection.

Main Methods:

  • Serum samples were processed using solid-phase extraction (SPE).
  • Quantification was performed using liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS).
  • Method validation included assessment of the limit of quantification (LLOQ) and limit of detection (LLOD), precision, and accuracy.

Main Results:

  • The developed LC-HRMS method achieved an LLOQ of 25 pg/mL and an LLOD of 12.5 pg/mL.
  • Precision and accuracy bias were within acceptable limits (<10%).
  • LNG levels in serum from Mirena® users ranged from 37 to 219 pg/mL (n=12).
  • LNG was detected in 8 out of 22 patients with suspected intrauterine device (IUD) expulsion, with concentrations ranging from 26 to 1272 pg/mL.

Conclusions:

  • A sensitive, fast, and simple LC-HRMS method was successfully developed for detecting trace levels of levonorgestrel in serum.
  • This method provides a valuable tool for monitoring LNG concentrations in various clinical scenarios, including IUD use and expulsion assessment.