Method for determining trace imatinib in blood sample and application thereof to zero phase clinical trial

Abstract

The invention relates to a method for determining trace imatinib in a blood sample and application to zero phase clinical trial, in particular, the invention relates to a method for determining imatinib or pharmaceutical salts of the imatinib in a biological sample. The method adopts the high performance liquid chromatography-tandem mass spectrum for determination and comprises the following steps and the testing conditions: treatment of a tested sample, determination of the sample, and determining a liquid chromatogram condition and a mass spectrum condition and the like. The invention also relates to application of imatinib or pharmaceutical salts of the imatinib to zero phase clinical trial and application of the method to pharmacokinetics experimental study of imatinib or pharmaceutical salts. The result shows that the detection method with the above characteristics can be beneficially used for detecting the concentration of imatinib or pharmaceutical salts of the imatinib such as mesylate in the biological sample such as blood plasma in the medicine zero phase clinical trial. The chemical structure of imatinib mesylate is shown in the description.

Description

Technical field [0001] The present invention belongs to the field of medical technology and relates to a method for measuring drugs, in particular to a method for measuring drugs in biological samples such as plasma, and more particularly to a method for measuring trace amounts of anti-cancer drugs in biological samples such as plasma. Determination of tinib and its medicinal salts. The present invention also relates to the application of this method in phase zero clinical trial research of drugs. Background technique [0002] Imatinib Mesylate is a selective tyrosine kinase inhibitor developed by Swiss Novartis. It is an aniline quinazoline compound and is selective for the tyrosine kinase activity of P210 protein. Inhibitor, targeting the abnormal protein Bcr-Abl with tyrosine kinase activity produced by Ph chromosome positive (Ph+) chronic myeloid leukemia (CML). The FDA approved it for the treatment of chronic myelogenous leukemia in May 2001. In February 2002, the FDA...

AI Technical Summary

Problems solved by technology

According to the general norms of phase zero clinical trials of drugs, in this phase zero clinical trial of drugs, the dose of the subject once a day is 4mg. After taking this very low dose, the drug dose in the subject's body fluids such as plasma will Lower, directly caused the problem of difficult determination of blood drug concentration, because the existing detection method of imatinib plasma drug concentration is not suitable for the detection of this extremely low dose, may not be detected and / or the detection value is different from the actual values ​​vary widely, and other detection issues

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