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首页> 外文期刊>American Journal of Analytical Chemistry >Rapid LC-ESI-MS-MS Method for the Simultaneous Determination of Sitagliptin and Pioglitazone in Rat Plasma and Its Application to Pharmacokinetic Study
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Rapid LC-ESI-MS-MS Method for the Simultaneous Determination of Sitagliptin and Pioglitazone in Rat Plasma and Its Application to Pharmacokinetic Study

机译：同时测定大鼠血浆中西格列汀和吡格列酮的快速LC-ESI-MS-MS方法及其在药代动力学研究中的应用

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A liquid chromatography tandem mass spectrometry (LC-MS/MS) based method was developed for the simultaneous monitoring plasma levels of Sitagliptin (STG) and Pioglitazone (PIO) for applicability to pharmacokinetic studies. The method was based on HPLC separation on the reversed phase Phenomenex Synergy C18 column (30 mm length, 4.6 mm internal diameter, and 4.0 μm particle size) at a temperature of 40?C using a binary gradient mobile phase consisting of methanol and 2 mM ammonium acetate buffer pH adjusted to 4.5 with acetic acid, at a flow rate of 1 mL?min?1. Tolbutamide was used as an internal standard. Detection of analytes was achieved with LC-MS/MS system in Multiple Reaction Monitoring (MRM) mode. The method was validated over concentration range of 10.98 - 2091.77 ng?mL?1 for SIT and 8.25 - 1571.63 ng?mL?1 for PIO and lower limit of quantification was 10.98 ng?mL?1 and 8.25 ng?mL?1 for STG and PIO respectively. Recoveries from spiked controls were within acceptance criteria for all the analytes and internal standard at all QC levels. Within batch and between batch accuracy for STG was found within 96.9% - 100.3% and for PIO was found within 100.0% - 104.3%. Within batch and between batch precision for STG was less than 3.1% CV (coefficient of variation) and for PIO was less than 5.3% CV at all concentrations levels. This method was successfully applied to monitor pharmacokinetics profile of both STG and PIO on simultaneous oral administration to rats. This method can be applicable for pharmacokinetic drug-drug interaction studies.
机译：开发了一种基于液相色谱串联质谱法（LC-MS / MS）的方法，用于同时监测西格列汀（STG）和吡格列酮（PIO）的血浆水平，以用于药代动力学研究。该方法基于反相Phenomenex Synergy C18色谱柱（30 mm长，4.6 mm内径和4.0μm粒径）的HPLC分离，使用由甲醇和2 mM组成的二元梯度流动相乙酸铵缓冲液的pH用乙酸调节至4.5，流速为1 mL？min？1。甲苯磺丁酰胺用作内标。使用LC-MS / MS系统以多反应监测（MRM）模式实现分析物的检测。该方法在SIT的浓度范围为10.98-2091.77 ng？mL？1时得到验证，PIO的浓度范围为8.25-1571.63 ng？mL？1，STG的定量下限为10.98 ng？mL？1和8.25 ng？mL？1和PIO分别。在所有质控水平下，加标对照的回收率均在所有分析物和内标的接受标准之内。在批内和批之间，STG的精度在96.9％-100.3％之内，而PIO的精度在100.0％-104.3％之内。在所有浓度水平下，STG的批内和批间精度均低于3.1％CV（变异系数），PIO均低于5.3％CV。该方法已成功应用于监测同时口服给予大鼠的STG和PIO的药代动力学。该方法可用于药代动力学药物相互作用研究。

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