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Ultrafiltration and UPLC-MS/MS (ultra-high performance liquid chromatography tandem mass spectrometry) method for measuring concentration of free docetaxel in human plasma

A technology of docetaxel and plasma, applied in the field of analysis, to achieve the effects of strong specificity, good reproducibility, and short analysis time

Active Publication Date: 2013-12-18
CANCER INST & HOSPITAL CHINESE ACADEMY OF MEDICAL SCI
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Problems solved by technology

[0007] In the prior art, there is no method for the determination of free docetaxel concentration after intravenous infusion of docetaxel lipid microsphere injection in advanced cancer patients without radiolabeling

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  • Ultrafiltration and UPLC-MS/MS (ultra-high performance liquid chromatography tandem mass spectrometry) method for measuring concentration of free docetaxel in human plasma
  • Ultrafiltration and UPLC-MS/MS (ultra-high performance liquid chromatography tandem mass spectrometry) method for measuring concentration of free docetaxel in human plasma
  • Ultrafiltration and UPLC-MS/MS (ultra-high performance liquid chromatography tandem mass spectrometry) method for measuring concentration of free docetaxel in human plasma

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Embodiment Construction

[0033] In order to describe the present invention more clearly, the specific implementation manners of the present invention will be described in more detail below through specific implementation examples. However, it should be understood that the specific implementation examples described below are only used to illustrate the present invention, and are not used to limit the present invention, and the materials, reagents, instruments and operating conditions used are only representative and are not intended to be used for the present invention. limited to the cases listed. Those skilled in the art can make changes and improvements to the present invention without departing from the protection scope defined by the claims of the present invention by reading the following descriptions, and these changes and improvements are also within the protection scope of the present invention.

[0034] 1 Instruments, materials and reagents

[0035] 1.1 Instruments Waters ultra-high performa...

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Abstract

The invention relates to an ultrafiltration and UPLC-MS / MS (ultra-high performance liquid chromatography tandem mass spectrometry) method for measuring concentration of free docetaxel in human plasma and provides a method for measuring the concentration of the free docetaxel in the plasma after docetaxel lipid microsphere injection. The method comprises an ultrafiltration (UF) step and a UPLC-MS / MS analysis step. The UF-UPLC-MS / MS method which is high in sensitivity and specificity and good in reproducibility is established on the premise that the balance of a combination medicine-free medicine in the plasma is not damaged. The method used for measuring the concentration of the free medicine and established for first time meets the biological sample analysis requirements of Guide for the Research of Chemical Drug and Clinical Pharmacokinetics issued by CFDA in 2005 in accuracy, precision, specificity, stability, extracting recovery rate and matrix effect.

Description

technical field [0001] The invention relates to a method for determining the concentration of free docetaxel in plasma, belonging to the technical field of analysis. The method of the present invention uses ultrafiltration combined with UPLC-MS / MS to measure the concentration of free docetaxel in plasma. The invention can be used for the determination of free docetaxel concentration after intravenous infusion of docetaxel lipid microsphere injection for patients with advanced cancer. Background technique [0002] Docetaxel is almost insoluble in water. Clinical docetaxel preparations such as taxotere use Tween 80 as a solubilizer, which increases solubility and causes adverse reactions, including severe allergic reactions and fluid retention. Docetaxel lipid microsphere injection does not contain organic solvents and Tween 80, significantly reduces bone marrow toxicity, avoids direct contact between the drug and the inner wall of blood vessels, and can provide essential fat...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 石远凯韩晓红杜萍
Owner CANCER INST & HOSPITAL CHINESE ACADEMY OF MEDICAL SCI
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