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Method for determining apatinib drug concentration in human plasma

A technology of apatinib and drug concentration, which is applied in the field of determination of apatinib drug concentration in human plasma, can solve the problems of consumption of organic solvents, long analysis time, large lower limit of quantification, etc., and achieves good reproducibility and sensitivity The effect of high, short analysis time

Inactive Publication Date: 2019-01-01
沈阳和合医学检验所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The determination of blood drug concentration in the body of most tumor drugs in China mostly adopts liquid chromatography and liquid phase tandem mass spectrometry. The former takes a long time to analyze, consumes a lot of organic solvents, and has a large lower limit of quantification.

Method used

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  • Method for determining apatinib drug concentration in human plasma

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Embodiment 1

[0034] A method for measuring the drug concentration of apatinib in human plasma, which is detected by high performance liquid chromatography tandem mass spectrometry, comprising the following steps:

[0035] (1) Preparation of standard working solution

[0036] Accurately weigh 1.02 mg of apatinib standard substance and place it in a 1.5mL centrifuge tube, accurately add 1.02mL of pure methanol solution to dissolve, and obtain standard stock solution A, that is, apatinib solution with a concentration of 1mg / mL. Stock solution A was diluted with pure methanol solution, diluted into apatinib solutions with concentrations of 0.04, 0.1, 0.2, 0.5, 1.0, 4.0, 10.0, 20.0, 40.0ug / mL, and stored at -80°C;

[0037] (2) Preparation of internal standard working solution

[0038] Accurately weigh 1.0 mg of benazeprilat standard substance and place it in a 1.5 mL centrifuge tube, accurately add 1.0 mL of pure methanol solution to dissolve to obtain standard stock solution B, dilute standar...

Embodiment 2

[0046] (1) Preparation of standard working solution

[0047] Accurately weigh 1.02 mg of apatinib standard substance and place it in a 1.5mL centrifuge tube, accurately add 1.02mL of pure methanol solution for dissolution to obtain standard stock solution A, that is, apatinib solution with a concentration of 1mg / mL, and standard Stock solution A was diluted with pure methanol solution, diluted into apatinib solutions with concentrations of 0.04, 0.1, 0.2, 0.5, 1.0, 4.0, 10.0, 20.0, 40.0ug / mL, and stored at -80°C;

[0048] (2) Preparation of internal standard working solution

[0049] Accurately weigh 1.0 mg of benazeprilat standard substance and place it in a 1.5 mL centrifuge tube, accurately add 1.0 mL of pure methanol solution to dissolve to obtain standard stock solution B, dilute standard stock solution B with pure methanol to obtain a concentration of 5ug / mL internal standard working solution, and stored at -80°C;

[0050] (3) Detection of centrifugation of blood

[0...

Embodiment 3

[0057] (1) Preparation of standard working solution

[0058] Accurately weigh 1.02 mg of apatinib standard substance and place it in a 1.5mL centrifuge tube, accurately add 1.02mL of pure methanol solution for dissolution to obtain standard stock solution A, that is, apatinib solution with a concentration of 1mg / mL, and standard Stock solution A was diluted with pure methanol solution, diluted into apatinib solutions with concentrations of 0.04, 0.1, 0.2, 0.5, 1.0, 4.0, 10.0, 20.0, 40.0ug / mL, and stored at -80°C;

[0059] (2) Preparation of internal standard working solution

[0060] Accurately weigh 1.0 mg of benazeprilat standard substance and place it in a 1.5 mL centrifuge tube, accurately add 1.0 mL of pure methanol solution to dissolve to obtain standard stock solution B, dilute standard stock solution B with pure methanol to obtain a concentration of 5ug / mL internal standard working solution, and stored at -80°C;

[0061] (3) Detection of centrifugation of blood

[0...

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Abstract

The invention relates to the technical field of clinical plasma concentration detection for anti-tumor drugs and especially relates to a method for determining apatinib drug concentration in human plasma. HPLC-MS / MS method is adopted for determining apatinib drug concentration in human plasma and comprises the steps of pretreatment of a blood sample and HPLC-MS / MS (High Performance Liquid Chromatography-Mass Spectrum / Mass Spectrum) analysis. An internal standard method is adopted for determining the apatinib drug concentration in the to-be-determined blood sample. In the invention, the internal standard method is combined with the HPLC-MS / MS method, so that the accuracy of the determining result is improved, the system error is eliminated, the analysis time is shortened, the detection process is simple, convenient and quick, the detection for the apatinib drug concentration in patient body in the clinic treatment is facilitated, and an experimental basis is supplied for the individualadministration of the apatinib and the reduction of toxic and side effects.

Description

technical field [0001] The invention relates to the technical field of clinical blood drug concentration detection of antineoplastic drugs, in particular to a method for measuring the drug concentration of apatinib in human plasma. Background technique [0002] Apatinib is a new oral small molecule tyrosine kinase inhibitor of the eight intracellular APT binding sites of VEGFR2. It has good therapeutic effect and safety on gastric cancer. It is mainly used clinically for advanced gastric adenocarcinoma or gastric cancer. -Third-line or above treatment for test-tube junction adenocarcinoma. Due to the large individual differences in the metabolic process in the body, the blood drug concentration in the body is closely related to the clinical efficacy and adverse reactions. It is of great significance in clinical drug use to detect the blood drug concentration to adjust the dosage and frequency of medication and reduce adverse reactions. [0003] At present, there are few rep...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 王琳徐恒宇
Owner 沈阳和合医学检验所有限公司
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