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Determination of human insulin in dog plasma by a selective' liquid, chromatography-tandem mass spectrometry method:. Application to a pharmacokinetic study

机译:用选择性'液体,色谱 - 串联质谱法测定犬血浆中人胰岛素的测定: 应用于药代动力学研究

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摘要

A simple, sensitive and selective LC-MS/MS method for quantitative analysis of human insulin was developed) and validated in dog plasma. Insulin glargine was used as the internal standard. After a simple step of solid-phase extraction, the chromatographic separation of human insulin was achieved by using InertSustain Bio C18 column with a mobile phase of acetonitrile containing 1% formic acid (A) water containing 1% formic acid (B). The detection was performed by positive ion electrospray ionization in multiple-reaction monitoring (MRM) mode. Good linearity was observed in the concentration range of 1-1000 IU/mL (r2 0.99), and the lower limit of quantification was 1 iilU/mL (equal to 38.46 pg/mL). The intra-and inter-day precision (expressed as relative standard deviation, RSD) of human insulin were 512.1% and 513.0%, respectively, and the accuracy (expressed as relative erior, RE) was in the range of-7.23-11.9%. The recovery and matrix effect were both within acceptable limits. This method was successfully applied for the phannicokinetic study of human insulin in dogs ' after subcutaneous administration.
机译:开发了一种简单,灵敏和选择性的LC-MS / MS / MS方法,用于人胰岛素的定量分析,并在狗质等离子体中验证。胰岛素甘油用作内标。在固相提取的简单步骤之后,通过使用含有1%甲酸(A)水的乙腈的流动相,通过含有1%甲酸(B)的甲酸(A)水的流动相,实现人胰岛素的色谱分离。通过在多反应监测(MRM)模式下通过正离子电喷雾电离进行检测。在1-1000IU / mL(R2> 0.99)的浓度范围内观察到良好的线性度,并且量化的下限为1Iilu / ml(等于38.46pg / ml)。人胰岛素的日内和日间常见的精度(表达为相对标准偏差,RSD)分别为512.1%和513.0%,并且精度(表达为相对的ERIOR,RE)在-7.23-11.9%的范围内。恢复和矩阵效应都在可接受的限度范围内。该方法已成功应用于皮下施用后犬人胰岛素的疫苗内研究。

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