Validation and application of HPLC–ESI–MS/MS method for the determination of irsogladine

Acta Chromatographicae

Hong S.-Y.¹  Park Je Won²  Hoang N. H.³  Huong N. L.³ 

[1] 1School of Biosystem and Biomedical Science, Korea University, Seoul 02841, Republic of Korea;1School of Biosystem and Biomedical Science, Korea University, Seoul 02841, Republic of KoreaAuthor for correspondence: [e-mail];2Department of BT Convergent Pharmaceutical Engineering, SunMoon University, Chungnam 31460, Republic of Korea

关键词: Irsogladine;    human plasma;    HPLC–ESI–MS/MS;    bioequivalence study;   

DOI  :  10.1556/1326.2017.00024

学科分类：化学（综合）

来源: Akademiai Kiado Rt.

【 摘 要 】

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. 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/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 (relative standard deviation, RSD) of irsogladine spiked into quality control samples were <7%, and their accuracies were between 96.6% and 102.1%. The calibration curve for irsogladine spiked into human plasma was linear over the range from 1.8 to 100 ng mL−1 with lower limit of quantification at 1.8 ng mL−1. The established method was successfully applied for a bioequivalence study of irsogladine.

【 授权许可】

Unknown