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An Accurate and Effective Method for Measuring Osimertinib by UPLC-TOF-MS and Its Pharmacokinetic Study in Rats

Song-Tao Dong1,2, Ying Li3, Hao-Tian Yang4

  • 1National Clinical Drug Monitoring Center, Department of Pharmacy, Hebei Province General Center, Shijiazhuang 050051, China. dongsongtao8886@163.com.

Molecules (Basel, Switzerland)
|November 9, 2018
PubMed

Insights

A new method quantifies osimertinib in rat plasma using ultra-performance liquid chromatography-time of flight mass spectrometry (UPLC-TOF-MS). This validated technique accurately measures osimertinib, aiding pharmacokinetic studies.

Area of Science:

  • Analytical Chemistry
  • Pharmacology
  • Biochemistry

Background:

  • Osimertinib is a key treatment for advanced epidermal growth factor receptor (EGFR) T790M mutation-positive tumors.
  • Accurate quantification of osimertinib is crucial for understanding its behavior in vivo.
  • Existing analytical methods may require enhancement for specific applications like pharmacokinetic studies.

Purpose of the Study:

  • To develop and validate an original analytical method for quantifying osimertinib in rat plasma.
  • To assess the method's specificity, accuracy, and precision.
  • To apply the validated method to pharmacokinetic studies in Sprague-Dawley (SD) rats.

Main Methods:

  • Ultra-performance liquid chromatography with time of flight mass spectrometry (UPLC-TOF-MS) was employed.
  • Acetonitrile was used for protein precipitation, with sorafinib as the internal standard.
  • Chromatography was performed on a Waters XTerra MS C18 column using a mobile phase of acetonitrile and water with 0.1% ammonia.

Main Results:

  • The developed UPLC-TOF-MS method demonstrated high specificity, accuracy, and precision.
  • Intra-day and inter-day relative standard deviations (RSD) were within acceptable ranges (5.38–9.76% and 6.02–9.46%, respectively).
  • Extraction recovery (84.31–96.14%) and matrix effects (91.46–97.18%) were within acceptable limits.

Conclusions:

  • A robust and validated UPLC-TOF-MS method for osimertinib quantification in rat plasma was successfully established.
  • The method's performance characteristics confirm its suitability for analytical purposes.
  • The validated method was effectively utilized in the pharmacokinetic analysis of osimertinib in SD rats.
Keywords:
UPLC-TOF-MSosimertinibpharmacokineticsrat

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