Determination of irsogladine using HPLC-ESI-MS/MS in human plasma: Application to bioequivalence study

Nguyen Huu Hoang, Nguyen Lan Huong, Sung Yong Hong, Je Won Park

Research output: Contribution to journalArticle

Abstract

A highly sensitive analytical tool for the fast quantification of irsogladine in human plasma was developed. Cleanup using a solid-phase extraction technique is a simple method for extracting both irsogladine and lamotrigine (internal standard) spiked into human plasma: 89.4 ± 2.4% for irsogladine and 85.9 ± 3.4% for lamotrigine. The resolvable separation of both analytes through reversed-phase high-performance liquid chromatography (HPLC) was carried out within 5 min. The HPLC-electrospray ionization (ESI)-tandem mass spectrometry (MS) method, which was operated in a selected reaction monitoring mode specific to the target analytes, was verified for use in the quantification of irsogladine. The inter- and intra-day precision (RSD) were <4% and their accuracies were between 85.9 to 89.8%. The calibration curve for irsogladine spiked into human plasma was linear over the range from 1 to 100 ng/mL; the limit of quantification was estimated to be 1.8 ng/mL. The established method was successfully applied for a bioequivalence study of irsogladine.

Original languageEnglish
Pages (from-to)1894-1898
Number of pages5
JournalLatin American Journal of Pharmacy
Volume35
Issue number8
Publication statusPublished - 2016 Jan 1

Keywords

  • Bioequivalence study
  • HPLC-ESI-MS/MS
  • Human plasma
  • Irsogladine

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Drug Discovery

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