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 journalArticlepeer-review

    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

    Bibliographical note

    Funding Information:
    This work was supported by the National Research Foundation of Korea (NRF) grant (2015R1A2A2A01002524), and by the grant (PJ011066) funded by the Next-Generation BioGreen21 program, Rural Development Administration.

    Publisher Copyright:
    © 2016, Colegio de Farmaceuticos de la Provincia de Buenos Aires. All rights reserved.

    Keywords

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

    ASJC Scopus subject areas

    • Pharmaceutical Science

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