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Determination of Cimotinib Concentration in Human Plasma by Uplc-MS/MS Method

A blood plasma, Chinese and Western technology, applied in the field of UPLC-MS/MS method to determine the concentration of simotinib in human plasma, can solve the problems of expensive method, unsatisfactory detection, complicated procedure, etc., and achieve the effect of good linear relationship

Active Publication Date: 2015-10-21
JIANGSU SIMCERE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The pretreatment method of liquid-liquid extraction is cumbersome and time-consuming, and cannot meet the detection of large samples in clinical pharmacokinetics
Solid-phase extraction of nine TKI drugs in a 96-well plate has also been reported recently, but this method is very expensive and complicated [25]
At present, there is no relevant literature reporting the methodology for the detection of simotinib concentration in biological samples

Method used

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  • Determination of Cimotinib Concentration in Human Plasma by Uplc-MS/MS Method
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  • Determination of Cimotinib Concentration in Human Plasma by Uplc-MS/MS Method

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Embodiment Construction

[0059] 1. Methods and results

[0060] 1.1. Drugs and reagents

[0061] Simotinib standard product was provided by Jiangsu Simcere Pharmaceutical Co., Ltd. (purity 99.8%), internal standard erlotinib standard product was provided by Jiangsu Simcere Pharmaceutical Co., Ltd. (purity 99.3%). Chromatographically pure methanol was purchased from Fisher Company, formic acid and ammonium formate were purchased from Sigma Company, and the experimental water was ultrapure water.

[0062] 1.2. Equipment and analysis conditions

[0063] 1.2.1 Chromatographic conditions:

[0064] Mobile phase: A: 0.1% formic acid in water, 10 mM ammonium formate B: Methanol

[0065] Flow rate: 0.2mL / min

[0066] Injection volume: 2μL

[0067] Column temperature: 25°C

[0068] Temperature inside the injector: 5°C

[0069] Mobile phase gradient settings:

[0070]

[0071] 1.2.2 Mass spectrometry conditions:

[0072] Electrospray ionization source (ESI), MRM multi-ion reaction detection, positive...

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Abstract

The invention relates to an ultra high performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS) method for determination of the simotinib concentration in human blood plasma. The invention provides the method for detecting the simotinib concentration in the blood plasma, wherein the simotinib concentration in the blood plasma is analyzed by the UPLC-MS / MS method. The method preferably adopts a methanol protein precipitation method to pretreat a sample, takes erlotinib hydrochloride as an internal standard, adopts a ZORBAX SB-C8 chromatographic column as an analytical column, and adopts electrospray ionization (ESI+) tandem mass spectrometry to detect. The extraction recovery rate of the sample of the method is greater than 90%, and a matrix effect does not appear. The method specificity, repeated freeze thawing stability, long-term cryopreservation stability and dilution effect are verified, and the method is successfully applied in detection of the plasma concentration of a patient given simotinib hydrochloride tablet treatment.

Description

technical field [0001] The present invention relates to a method for analyzing the concentration of simotinib in blood plasma. In the method of the present invention, the concentration of simotinib in plasma is analyzed by using ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS / MS), which realizes the rapid, sensitive and specific analysis of simotinib concentration in plasma . Background technique [0002] Lung cancer is currently the leading cause of cancer-related death worldwide, accounting for approximately 1.4 million deaths each year [1]. Non-small cell lung cancer (NSCLC) accounts for 85% of the total lung cancer [2], and adenocarcinoma is the main pathological type. The vast majority of NSCLC is still dominated by chemotherapy, and effective [3]. [0003] Epidermal growth factor receptor (EGFR), a tyrosine kinase receptor (receptor tyrosine kinase, RTK), plays an important role in cell differentiation, proliferation, angiogenesis and ...

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
Inventor 石远凯韩晓红李宁
Owner JIANGSU SIMCERE PHARMA