Validation of a sensitive LC-MS assay for quantification of glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: An OPRU Network study
Validation of a sensitive LC-MS assay for quantification of glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: An OPRU Network study
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DOI：
10.1016/j.jchromb.2007.10.010
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发表时间：
2007-12-01
影响因子：
3
通讯作者：
Unadkat, Jashvant D.
中科院分区：
文献类型：
--
作者：
Naraharisetti, Suresh Babu;Kirby, Brian J.;Unadkat, Jashvant D.
格列本脲（格列本脲，INN）。第二代磺酰脲广泛用于治疗妊娠糖尿病（GDM）。先前报告的分析方法均未提供妊娠期间格列本脲的预期亚纳克/mL母体和脐带血浆浓度的足够灵敏度。我们开发并验证了一种灵敏、低样品体积的液相色谱-质谱（LC-MS）方法，用于同时测定人血浆（0.5 mL）或尿液（0.1 mL）中的格列本脲（GLY）及其代谢产物4-反式羟基格列本脲（M1）。血浆中GLY和M1的定量限（LOQ）分别为0.25和0.40 ng/mL，而尿液中M1的定量限为1.06 ng/mL。如通过质量控制样品测量的，测定的精确度（变异系数%）< 15%，而准确度（与预期的偏差%）范围为-10。14.3%。我们发现GLY代谢产物M1以葡萄糖醛酸结合物的形式经尿液排泄。(C)2007年Elsevier B. V.。All rights reserved.
Glyburide (glibenclamide, INN). a second generation sulfonylurea is widely used in the treatment of gestational diabetes mellitus (GDM). None of the previously reported analytical methods provide adequate sensitivity for the expected sub-nanogram/mL maternal and umbilical cord plasma concentrations of glyburide during pregnancy. We developed and validated a sensitive and low sample volume liquid chromatographic-mass spectrometric (LC-MS) method for simultaneous determination of glyburide (GLY) and its metabolite, 4-transhydroxy glyburide (M1) in human plasma (0.5 mL) or urine (0.1 mL). The limits of quantitation (LOQ) for GLY and M1 in plasma were 0.25 and 0.40 ng/mL, respectively whereas it was 1.06 ng/mL for M1 in urine. As measured by quality control samples, precision (% coefficient of variation) of the assay was < 15% whereas the accuracy (% deviation from expected) ranged from -10. 1 to 14.3%. We found that the GLY metabolite, M1 is excreted in the urine as the glucuronide-conjugate. (C) 2007 Elsevier B.V.. All rights reserved.