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Detection of drug concentration of osimertinib in human plasma and/or cerebrospinal fluid by combining UPLC-MS/MS

A technology for human plasma and cerebrospinal fluid, which is applied in measurement devices, instruments, scientific instruments, etc., can solve the problem of not measuring the concentration of osimertinib

Active Publication Date: 2017-11-07
CANCER INST & HOSPITAL CHINESE ACADEMY OF MEDICAL SCI
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Problems solved by technology

So far, only two studies have determined the concentration of human plasma, and the sample pretreatment method used is the salting-out liquid-liquid extraction method [11-12], and there is no methodological report on the determination of the concentration of osimertinib in human cerebrospinal fluid

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  • Detection of drug concentration of osimertinib in human plasma and/or cerebrospinal fluid by combining UPLC-MS/MS
  • Detection of drug concentration of osimertinib in human plasma and/or cerebrospinal fluid by combining UPLC-MS/MS
  • Detection of drug concentration of osimertinib in human plasma and/or cerebrospinal fluid by combining UPLC-MS/MS

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Embodiment Construction

[0042] In the method of the present invention, the following preferred conditions can be considered. The method includes the treatment of plasma and cerebrospinal fluid samples with acetonitrile protein precipitation. The liquid phase conditions are ACQUITY UPLC BEH C18 (50mm×2.1mm, 1.7μm), and the mobile phase is A: 0.1% formic acid 10mM ammonium formate water; B: 0.5% Formic acid acetonitrile, 0.3mL·min -1 Gradient elution. The mass spectrometry method adopts electrospray ionization, positive ion multi-reaction monitoring mode, monitoring ion pairs: osimertinib m / z 500.38→71.88 and internal standard pazopanib m / z 438.21→357.18. The inventor conducted a methodological investigation in accordance with the “Guidelines for Validation of Quantitative Analysis Methods for Biological Samples” in the 2015 Chinese Pharmacopoeia, and detected the drug concentration of osimertinib in the plasma and cerebrospinal fluid of the subjects, and initially verified the applicability of the meth...

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Abstract

The invention relates to detection of the drug concentration of osimertinib in human plasma and / or cerebrospinal fluid by combining UPLC-MS / MS. According to the present invention, the method for determining the drug concentration of osimertinib in human plasma and / or cerebrospinal fluid through an ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS / MS) is provided, wherein formic acid-containing ammonium formate water-formic acid acetonitrile is used as a mobile phase so as to perform the method; and the method has advantages of good specificity and high sensitivity, and is used for the detection of clinical pharmacokinetic samples, wherein the linearity is good when the osimertinib concentration is 2-500 ng.ml<-1> in the plasma sample and the osimertinib concentration is 0.5-20 ng.ml<-1> in the cerebrospinal fluid sample.

Description

Technical field [0001] The invention relates to a method for detecting the concentration of a drug. Specifically, the present invention relates to a method for determining the drug concentration of osimertinib (AZD9291) in human plasma and / or cerebrospinal fluid by ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS / MS). Background technique [0002] introduction [0003] Lung cancer is one of the tumors with the highest morbidity and mortality in the world, with 1.8 million new cases and 1.5 million deaths every year [1]. In the disease progression of lung cancer patients, about 40%-50% of patients progress to brain metastases. Brain metastasis includes brain parenchymal metastasis and meningeal metastasis. Lung cancer patients with brain metastases usually have a worse quality of life, which affects the overall survival time of patients [2]. [0004] Epidermal growth factor receptors are widely distributed on the surface of mammalian epithelial cells, fibr...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 石远凯韩晓红宋媛媛
Owner CANCER INST & HOSPITAL CHINESE ACADEMY OF MEDICAL SCI
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