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首页> 外文期刊>Journal of mass spectrometry: JMS >Simultaneous quantitation of IC87114, roflumilast and its active metabolite roflumilast N-oxide in plasma by LC-MS/MS: Application for a pharmacokinetic study
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Simultaneous quantitation of IC87114, roflumilast and its active metabolite roflumilast N-oxide in plasma by LC-MS/MS: Application for a pharmacokinetic study

机译：LC-MS / MS同时定量测定血浆中IC87114，罗氟司特及其活性代谢物罗氟司特N-氧化物：在药代动力学研究中的应用

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摘要

A sensitive and reliable high-performance liquid chromatography-mass spectrometry (LC-MS/MS) was developed and validated for simultaneous quantification IC87114, roflumilast (RFM), and its active metabolite roflumilast N-oxide (RFN) using tolbutamide as an internal standard. The analytes were extracted by using liquid-liquid extraction and separated on a reverse phase C_(18) column (50 mm × 3 mm i.d., 4.6 μ) using methanol: 2 mM ammonium acetate buffer, pH 4.0 as mobile phase at a flow rate 1 mL/min in gradient mode. Selective reaction monitoring was performed using the transitions m/z 398.3 > 145.9, 403.1 >186.9, 419.1 > 187.0 and 271.1 > 155.0 to quantify quantification IC87114, RFM, RFN and tolbutamide, respectively. The method was validated over the concentration range of 0.1-60 ng.mL~(-1) for RFM and RFN and 6 to 2980 ng.mL~(-1) for IC87114. Intra- and inter-day accuracy and precision of validated method were within the acceptable limits of <15% at all concentrations. Coefficients of correlation (r ~2) for the calibration curves were >0.99 for all analytes. The quantitation method was successfully applied for simultaneous estimation of IC87114, RFM and RFN in a pharmacokinetic drug-drug interaction study in Wistar rats.
机译：开发了灵敏可靠的高效液相色谱-质谱法（LC-MS / MS），并验证了使用甲苯磺丁酰胺作为内标的同时定量分析IC87114，罗氟司特（RFM）及其活性代谢物罗氟司特N-氧化物（RFN）的有效性。通过液-液萃取对分析物进行萃取，并使用甲醇：2 mM醋酸铵缓冲液，pH 4.0作为流动相，在反相C_（18）柱（50 mm×3 mm内径，4.6μ）上分离在梯度模式下为1 mL / min。使用转换m / z 398.3> 145.9、403.1> 186.9、419.1> 187.0和271.1> 155.0进行选择性反应监测，以分别量化IC87114，RFM，RFN和甲苯磺丁酰胺的定量。 RFM和RFN的浓度范围为0.1-60 ng.mL〜（-1），IC87114的浓度范围为6至2980 ng.mL〜（-1）验证了该方法。经验证的方法的日内和日间准确度和精密度在所有浓度下均在<15％的可接受范围内。对于所有分析物，校准曲线的相关系数（r〜2）均大于0.99。定量方法已成功用于Wistar大鼠药代动力学药物相互作用研究中的IC87114，RFM和RFN的同时估计。

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