High-performance liquid chromatography-electrospray ionization mass spectrometry determination of mitiglinide in human plasma and its pharmacokinetics

✍ Scribed by Jiabi Liang; Yuan Tian; Zunjian Zhang; Shudan Feng; Yanan Zhao; Guoguang Mao

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 151 KB
• Volume: 42
• Category: Article
• ISSN: 1076-5174
• DOI: 10.1002/jms.1139

✦ Synopsis

Abstract

A selective and sensitive method employing high‐performance liquid chromatography–electrospray ionization mass spectrometry was developed and validated for the determination of mitiglinide in human plasma.With gliclazide as the internal standard, mitiglinide was extracted from plasma with n‐hexane: = 80 : 20 (v/v). The organic layer was evaporated and the residue was redissolved in methanol: water (10 mM CH~3~COONH~4~, pH = 3.0) = 65 : 35 (v/v). An aliquot of 10 µl was chromatographically analyzed on a prepacked Shimadzu VP‐ODS (5 µm, 150 × 2.0 mm i.d.) using the mobile phase comprising methanol: water (10 mM CH~3~COONH~4~) = 65 : 35 (v/v) by means of selected‐ion monitoring mode mass spectrometry. Standard curves were linear (r^2^ = 0.9972) over the concentration range of 2.84–11 300 pmol/ml and had good accuracy and precision. The within‐ and between‐batch precisions of the method were within 15% of standard deviation. The lower limit of detection was 1.42 pmol/ml. The validated HPLC/ESI‐MS method has been successfully applied in the pharmacokinetics of mitiglinide in 12 healthy Chinese volunteers. Copyright © 2006 John Wiley & Sons, Ltd.