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Purpose <p>Mirogabalin is a gabapentinoid used to treat peripheral neuropathic pain. While its adverse effect profile is generally mild, postmortem toxicological data are currently unavailable. This study aimed to develop and validate a quantitative method for determining mirogabalin concentrations in postmortem blood and urine using liquid chromatography–tandem mass spectrometry (LC-MS/MS), and to evaluate its concentrations in a fatal multiple drug intoxication case involving mirogabalin.</p> Methods <p>Postmortem blood and urine specimens were collected during a forensic autopsy following a mirogabalin overdose. For method development and validation, blank blood and urine samples were spiked with mirogabalin standard solutions. Mirogabalin was extracted using the QuEChERS method, further purified using Captiva ND Lipids cartridges, and analyzed by LC-MS/MS. The method was validated according to the U.S. Food and Drug Administration bioanalytical guideline.</p> Results <p>The method demonstrated good linearity over the range of 0.2–100&#xa0;µg/mL (<i>r</i> &gt; 0.99), with an LLOQ of 0.1&#xa0;µg/mL. Mirogabalin concentrations in postmortem blood and urine were 1.99&#xa0;µg/mL and 3.56&#xa0;µg/mL, respectively. Accuracy and precision were within acceptable limits. Matrix effects were observed, indicating ion suppression. Recovery rates were generally within the recommended range. Mirogabalin also showed sufficient stability.</p> Conclusions <p>This is the first study to establish and validate an LC-MS/MS method for quantifying mirogabalin in postmortem blood and urine. The findings provide valuable data for forensic toxicological interpretation and evaluation of fatal intoxication cases associated with mirogabalin.</p>

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Quantitative analysis and method validation of mirogabalin in postmortem blood and urine using liquid chromatography–tandem mass spectrometry

  • 期刊论文

  • 发表日期：

    2026年3月23日

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  • Kenta Yuyama,
  • Masako Suzuki,
  • Itaru Yamagishi,
  • Hideki Nozawa,
  • Kayoko Minakata,
  • Koutaro Hasegawa

摘要

Purpose

Mirogabalin is a gabapentinoid used to treat peripheral neuropathic pain. While its adverse effect profile is generally mild, postmortem toxicological data are currently unavailable. This study aimed to develop and validate a quantitative method for determining mirogabalin concentrations in postmortem blood and urine using liquid chromatography–tandem mass spectrometry (LC-MS/MS), and to evaluate its concentrations in a fatal multiple drug intoxication case involving mirogabalin.

Methods

Postmortem blood and urine specimens were collected during a forensic autopsy following a mirogabalin overdose. For method development and validation, blank blood and urine samples were spiked with mirogabalin standard solutions. Mirogabalin was extracted using the QuEChERS method, further purified using Captiva ND Lipids cartridges, and analyzed by LC-MS/MS. The method was validated according to the U.S. Food and Drug Administration bioanalytical guideline.

Results

The method demonstrated good linearity over the range of 0.2–100 µg/mL (r > 0.99), with an LLOQ of 0.1 µg/mL. Mirogabalin concentrations in postmortem blood and urine were 1.99 µg/mL and 3.56 µg/mL, respectively. Accuracy and precision were within acceptable limits. Matrix effects were observed, indicating ion suppression. Recovery rates were generally within the recommended range. Mirogabalin also showed sufficient stability.

Conclusions

This is the first study to establish and validate an LC-MS/MS method for quantifying mirogabalin in postmortem blood and urine. The findings provide valuable data for forensic toxicological interpretation and evaluation of fatal intoxication cases associated with mirogabalin.