UPLC-MS/MS method for detecting concentrations of tafetinib and active metabolite SCR868 in human plasma

A technology of metabolites and human plasma, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of inapplicability and low sensitivity

Active Publication Date: 2016-05-11
南京力博维制药有限公司
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Problems solved by technology

The reported method for detecting the plasma concentration of tafitinib and SCR868 in dog plasma uses liquid-liquid extraction and has low sensitivity, which is not suitable for large-scale sample detection in clinical pharmacokinetic studies

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  • UPLC-MS/MS method for detecting concentrations of tafetinib and active metabolite SCR868 in human plasma
  • UPLC-MS/MS method for detecting concentrations of tafetinib and active metabolite SCR868 in human plasma
  • UPLC-MS/MS method for detecting concentrations of tafetinib and active metabolite SCR868 in human plasma

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Embodiment Construction

[0028] 1. In order to support its clinical pharmacokinetic research, the inventors established a fast and sensitive high performance liquid chromatography-tandemmass spectrometry (UPLC-MS / MS) method to detect tafitinib and its main activity in human plasma The plasma concentration of the metabolite SCR868 (N-desethyltafitinib). Plasma sample pretreatment uses 400ul acetonitrile protein precipitation, further diluted with purified water, and then uses AgilentZORBAXSB-C18column (3.5μm, 150mm×2.1mm) column, 45% acetonitrile and 55% 10mM ammonium formate 0.1% formic acid water, 0.25ml / min Isocratic elution was used for separation, the internal standard was prazosin hydrochloride, the mass spectrometry conditions were electrospray ionization (ESI), cation multiple reaction monitoring mode (MRM), and the monitoring ion pair was: tafitinib m / z425.2> 309.1, SCR868m / z397> 309.1, internal standard 384> 247.

[0029] 2. Materials and methods

[0030] 2.1. Reagents and drugs

[0031] Both tafi...

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Abstract

The invention relates to a UPLC-MS / MS method for detecting the concentrations of tafetinib and active metabolite SCR868 in human plasma. The invention provides the method for detecting the concentrations of the tafetinib and the active metabolite SCR868 in the human plasma through ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS / MS), wherein the method is implemented by adopting ammonium formate water-acetonitrile containing formic acid as a mobile phase. The method provided by the invention is good in specificity and high in sensitivity, the linear relation between the tafetinib and the SCR868 is good within the range of 0.2 to 50ng / mL of plasma, and the method is successfully applied to the detection of clinical pharmacokinetic samples.

Description

Technical field [0001] The invention relates to a method for detecting the concentration of a drug in human plasma. Specifically, the present invention relates to a method for determining the concentration of tafitinib and the active metabolite SCR868 in human plasma by ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS / MS). Background technique [0002] introduction [0003] Tyrosine kinase receptors (TKRs) play an important role in the occurrence, development and metastasis of tumors, which makes them a key target for tumor therapy [1]. As the first epidermal growth factor receptor inhibitor, Iressa, has achieved remarkable results in the treatment of EGFR-mutated non-small cell lung cancer patients [2], more tyrosine has emerged in the past few years Receptor inhibitors (TyrosineKinaseInhibitors, TKIs). However, more and more TKIs drugs still cannot fundamentally improve the survival and mortality of current tumors, as well as the problem of TKIs resist...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 石远凯韩晓红张妍
Owner 南京力博维制药有限公司
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