Chu N N, Li X N, Chen W L, Xu H R
Department of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai, PR China.
Pharmazie. 2007 Nov;62(11):825-9.
Chiglitazar is a dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist. A LC-MS/MS method for the determination of chiglitazar was developed and validated. The assay used 0.2 mL of plasma. 90% acetonitrile containing internal standard was used for protein precipitation. The mobile phase contained 70/30 (v/v) of methanol and water at a flow rate of 0.25 mL/min. Detection was by negative ion electrospray tandem mass spectrometry on a Sciex API 3000. The standard curve, which ranged from 2 to 1500 ng/mL, was fitted to a 1/x weighted quadratic regression model. The validation results demonstrated that the method was sensitive, rapid, selective and robust and provided satisfactory precision and accuracy. The method has been successfully used for the analysis of clinical samples in pharmacokinetic studies of chiglitazar.
西格列他钠是一种双靶点（α/γ）过氧化物酶体增殖物激活受体（PPAR）激动剂。建立并验证了一种采用液相色谱-串联质谱法（LC-MS/MS）测定西格列他钠的方法。该测定法使用0.2 mL血浆。含内标的90%乙腈用于蛋白沉淀。流动相由70/30（v/v）的甲醇和水组成，流速为0.25 mL/min。采用Sciex API 3000通过负离子电喷雾串联质谱进行检测。标准曲线范围为2至1500 ng/mL，采用1/x加权二次回归模型拟合。验证结果表明该方法灵敏、快速、具有选择性且稳健，具有令人满意的精密度和准确度。该方法已成功用于西格列他钠药代动力学研究中的临床样本分析。
