Development and validation of a RP-HPLC method for the quantitation of tofacitinib in rat plasma and its application to a pharmacokinetic study

Vijay Kumar S, Vinay Dhiman, Kalpesh Kumar Giri, Kuldeep Sharma, Mohd Zainuddin, Ramesh Mullangi*

*Corresponding author for this work

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

A novel, simple, specific, sensitive and reproducible high-performance liquid chromatography (HPLC) assay method has been developed and validated for the estimation of tofacitinib in rat plasma. The bioanalytical procedure involves extraction of tofacitinib and itraconazole (internal standard, IS) from rat plasma with a simple liquid-liquid extraction process. The chromatographic analysis was performed on a Waters Alliance system using a gradient mobile phase conditions at a flow rate of 1.0mL/min and C18 column maintained at 40±1°C. The eluate was monitored using an UV detector set at 287nm. Tofacitinib and IS eluted at 6.5 and 8.3min, respectively and the total run time was 10min. Method validation was performed as per US Food and Drug Administration guidelines and the results met the acceptance criteria. The calibration curve was linear over a concentration range of 182-5035ng/mL (r2=0.995). The intra- and inter-day precisions were in the range of 1.41-11.2 and 3.66-8.81%, respectively, in rat plasma. The validated HPLC method was successfully applied to a pharmacokinetic study in rats.

Original languageEnglish
Pages (from-to)1325-1329
Number of pages5
JournalBiomedical Chromatography
Volume29
Issue number9
DOIs
Publication statusPublished - 1 Sep 2015
Externally publishedYes

Keywords

  • HPLC
  • method validation
  • pharmacokinetics
  • rat plasma
  • tofacitinib

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