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Related Experiment Video

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Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
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UPLC-MS/MS method for determination of sofosbuvir in human plasma.

B M Gandhi1, A L Rao2, J V Rao3

  • 1Department of Pharmaceutical Analysis, Sri Vasavi Institute of Pharmaceutical Sciences, Tadepalligudem, AP, India.

Annales Pharmaceutiques Francaises
|May 13, 2017
PubMed
Summary

A new ultra-performance liquid chromatography-tandem mass spectrometry method accurately quantifies Sofosbuvir in human plasma. This validated assay is suitable for pharmacokinetic studies and clinical applications.

Keywords:
Human plasmaLa validation de méthodeMethod validationPlasma humainSofosbuvirStability studiesUPLC-MS/MSÉtudes de stabilité

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Area of Science:

  • Analytical Chemistry
  • Pharmacokinetics

Background:

  • Sofosbuvir is a key antiviral medication.
  • Accurate quantification in biological matrices is crucial for therapeutic drug monitoring and research.

Purpose of the Study:

  • To develop and validate a sensitive and rapid UPLC-ESI-MS/MS method for Sofosbuvir quantitation in human plasma.

Main Methods:

  • Liquid-liquid extraction of Sofosbuvir and deuterated internal standard (Sofosbuvir-d3) from plasma.
  • Analysis using ultra-performance liquid chromatography (UPLC) coupled with electrospray ionization tandem mass spectrometry (ESI-MS/MS).
  • Detection in multiple reaction monitoring (MRM) mode.

Main Results:

  • The method demonstrated high sensitivity and specificity, with minimal interference from the plasma matrix.
  • Linearity was established over a wide concentration range (4.063-8000.010 ng/mL) with excellent correlation coefficients (R² ≥ 0.9956).
  • Sofosbuvir exhibited good stability in plasma under various storage and handling conditions.

Conclusions:

  • The UPLC-ESI-MS/MS method is validated according to USFDA guidelines.
  • The assay is reliable and suitable for determining Sofosbuvir concentrations in human plasma.
  • This method can be applied to routine clinical analysis and pharmacokinetic studies of Sofosbuvir.