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Matrix-Assisted Laser Desorption Ionization (MALDI)

Matrix-assisted laser desorption ionization (MALDI) is a powerful analytical technique used in mass spectrometry. It enables the identification and characterization of various biomolecules, including proteins, peptides, nucleic acids, and carbohydrates. MALDI is an ionization technique, widely employed in biological and medical research, as well as in fields like pharmacology and biochemistry.The analyte of interest, a biomolecule or a mixture of biomolecules, is mixed with a suitable matrix...

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Metaxalone estimation in biological matrix using high-throughput LC-MS/MS bioanalytical method.

Dipanjan Goswami1, Arabinda Saha, Sanjay Gurule

  • 1Department of Clinical Pharmacology and Pharmacokinetics, Ranbaxy Laboratories Ltd., HSIDC, GP-5, Old Delhi Gurgaon Road, Udyog Vihar Industrial Area, Gurgaon 122 015, Haryana, India. dipanjan.goswami@ranbaxy.com

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|July 7, 2012
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Summary

A new tandem mass spectrometry method accurately measures metaxalone in human plasma. This validated assay includes crucial stability data for diverse clinical applications.

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Area of Science:

  • Analytical Chemistry
  • Pharmacology

Background:

  • Metaxalone is a skeletal muscle relaxant used for pain relief.
  • Existing bioanalytical methods for metaxalone lack comprehensive stability data in biological matrices like blood and plasma.

Purpose of the Study:

  • To develop and validate a high-throughput, accurate, and precise tandem mass spectrometry method for metaxalone quantification in human plasma.
  • To evaluate the stability of metaxalone in various plasma conditions (hemolyzed, lipemic, normal) and whole blood.

Main Methods:

  • Solid phase extraction (SPE) of metaxalone and metaxalone-d(3) from 200 μL human plasma.
  • Chromatographic separation using an Ascentis Express C18 column.
  • Detection via triple quadrupole tandem mass spectrometry in multiple reaction monitoring (MRM) mode with electrospray ionization (ESI).

Main Results:

  • The method demonstrated linearity over 0.105-10.081 μg/mL with an LLOQ of 0.105 μg/mL (r(2)≥0.99).
  • Intra- and inter-day precision and accuracy were within 6%, with mean recovery exceeding 78%.
  • No significant interference or matrix effects were observed, and stability was confirmed in various plasma types and blood.

Conclusions:

  • A robust and validated bioanalytical method for metaxalone in human plasma was established.
  • The method's stability profile supports its broad applicability in clinical studies involving metaxalone, including extended-release formulations.