Development and Application of Analytical Method for Simultaneous Quantification of Iopromide and Iodixanol in Human Plasma

人血浆中碘普罗胺和碘克沙醇同时定量分析方法的研制与应用

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Abstract

The purpose of this study is to develop and validate a simple and rapid analytical method using ultrahigh performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) for the simultaneous quantification of two commonly used contrast agents, iopromide and iodixanol, in human plasma. The separation of two compounds was analyzed utilizing an Agilent ZORBAX SB-C(18) column (2.1 × 100 mm, 3.5 μm) with an isocratic elution procedure. The mobile phase consisted of acetonitrile and 0.2% formic acid aqueous solution (14:86, V:V). A simple protein precipitation method was used to pretreat plasma samples. The iopromide and iodixanol exhibited excellent linearity between 2.0 and 400.0 μg/mL, with both R values exceeding 0.99. Recovery of iopromide ranged from 91.39% to 102.69%, and matrix effect varied between 87.88% and 104.08%; the relative standard deviation (RSD%) of intra- and interday precisions fell within the range of 1.29%-4.7%. For iodixanol, recovery ranged from 97.68% to 100.14%, and the matrix effect was between 87.88% and 96.64%, and RSD% values of intra- and interday precisions ranged from 1.58% to 8.2%. Method validation results all met methodological criteria. The UHPLC-MS/MS method was successfully developed and validated and then applied to determine two common contrast agents, iopromide and iodixanol, in human plasma.

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