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Method for detecting quetiapine in human plasma by HPLCMS-MS combination

A technology for quetiapine and human detection, applied in the field of biological analysis, can solve the problems of narrow quantitative range, low recovery rate, and more than 0.2mL plasma dosage, and achieve the effect of wide application range and good accuracy

Inactive Publication Date: 2019-06-18
NANJING HEALTHNICE MEDICAL TECH +2
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Problems solved by technology

[0005] Kangwei established a protein precipitation liquid mass spectrometry method in 2018 for the detection of quetiapine fumarate in blood. Although the detection limit and quantification limit of this method are low, the amount of plasma used is 0.2mL and the quantification range is narrow. Low rate, not suitable for large batch sample processing

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  • Method for detecting quetiapine in human plasma by HPLCMS-MS combination
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  • Method for detecting quetiapine in human plasma by HPLCMS-MS combination

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Embodiment Construction

[0041] The detection method of the present invention will be further described by the following examples in conjunction with the accompanying drawings, but these examples do not constitute any limitation to the present invention.

[0042] Materials and Methods

[0043] 1. Instruments and reagents

[0044] High-phase liquid chromatography (Shimadzu LC-20 series); mass spectrometry (API 3000, Applied Biosystems / Sciex); pure water meter (MilliDirectQ, Millipore); microbalance (XP6, METTLER TOLEDO); centrifuge (HeraeusMuitifuge X1R, ThermoFisher) ; Oscillator (LPD2500, LE PARD).

[0045] Acetonitrile (Merck, HPLC grade), water (ultrapure water, laboratory-made), formic acid (Aladdin, HPLC grade), isopropanol (Anhui Shilian Special Solvent Co., Ltd., HPLC grade), ammonium acetate (Aladdin, HPLC grade) grade) methanol (Merck, HPLC grade). Blank heparin sodium anticoagulated plasma was derived from healthy subjects. Quetiapine fumarate (China Institute for Food and Drug Control, ...

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Abstract

The invention belongs to the field of biological analysis and particularly relates to a method for detecting quetiapine in human plasma by HPLCMS-MS combination. The method comprises steps of (1), human plasma sample pretreatment; (2), liquid chromatography-mass spectrum combined detection, mobile phase A and mobile phase B are utilized as a mixed mobile phase for gradient elution, the mobile phase A is acetonitrile-water, the mobile phase B is ammonium acetate-water; and (3), determination of the concentration of the quetiapine in the human plasma. The method is advantaged in that deuteratedfumaric acid quetiapine is used as an internal marker, gradient elution is performed through utilizing an InertSustain C18 column, the deuterated internal marker and a determinand have the same retention time, chemical properties and matrix effects, and reproducibility and accuracy of concentration detection of the deuterated fumaric acid quetiapine in plasma are good. The method is used for evaluating bioequivalence of each quetiapine dosage form.

Description

technical field [0001] The invention belongs to the field of biological analysis, in particular to a method for quantitatively detecting the concentration of quetiapine in blood plasma by liquid mass spectrometry. Background technique [0002] Quetiapine fumarate is mainly a new non-classic antipsychotic drug. Clinical studies have shown that the drug is a safe and effective psychotropic drug that interacts with a variety of neurotransmitter receptors. The drug mainly acts on 5-hydroxytryptamine 2 receptors and D1, D2, and D4 receptors of dopamine, and is not only effective for positive symptoms of schizophrenia, but also effective for negative symptoms. Quetiapine fumarate has a quick onset time and mild adverse reactions, and has become the first-line drug for the treatment of schizophrenia and bipolar disorder. At present, there are few reports on the bioequivalence research methods of quetiapine fumarate, and the research in the Chinese population is even more limited. ...

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Application Information

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IPC IPC(8): G01N30/02G01N30/72G01N30/34G01N30/04G01N30/06G01N30/86
Inventor 高倩倩潘诗苑王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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