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HPLC-DAD method for determinating quetiapine drug concentration of human serum

A technology of drug concentration and quetiapine, which is applied in the field of clinical blood drug concentration monitoring of psychiatric drugs, can solve the problems of complex preprocessing, inaccurate results, and narrow quantitative analysis range, and achieves the effect of reducing reagent pollution.

Inactive Publication Date: 2019-01-04
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

However, the previous methods have problems such as complicated pre-treatment, low sensitivity, narrow quantitative analysis range, and external standard method can easily lead to inaccurate results.

Method used

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  • HPLC-DAD method for determinating quetiapine drug concentration of human serum
  • HPLC-DAD method for determinating quetiapine drug concentration of human serum
  • HPLC-DAD method for determinating quetiapine drug concentration of human serum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] (1) Preparation of standard working solution

[0043] (1) Preparation of standard working solution:

[0044] Accurately weigh 5.57mg of quetiapine fumarate standard substance (equivalent to 4.83mg of quetiapine mass) in a 15mL centrifuge tube, dissolve with methanol, and prepare stock solution S1 with a quetiapine concentration of 1.0mg / mL. Dilute the standard stock solution S1 with methanol to prepare quetiapine series standard working solutions containing 1.0, 2.0, 3.0, 6.0, 10, 20, and 60 μg / mL concentrations respectively, and store them in a -80°C refrigerator;

[0045] (2) Preparation of internal standard working solution

[0046] Accurately weigh 2.31 mg of genistein standard substance (equivalent to 2.30 mg of genistein) in a 5mL centrifuge tube, dissolve in methanol, and make a stock solution ISS1 with a concentration of 1.0 mg / mL, and use the standard stock solution ISS1 with Dilute with methanol to obtain an internal standard working solution with a concentr...

Embodiment 2

[0056] (1) Preparation of standard working solution

[0057] (1) Preparation of standard working solution:

[0058] Accurately weigh 5.57mg of quetiapine fumarate standard substance (equivalent to 4.83mg of quetiapine mass) in a 15mL centrifuge tube, dissolve with methanol, and prepare stock solution S1 with a quetiapine concentration of 1.0mg / mL. Dilute the standard stock solution S1 with methanol to prepare quetiapine series standard working solutions containing 1.0, 2.0, 3.0, 6.0, 10, 20, and 60 μg / mL concentrations respectively, and store them in a -80°C refrigerator;

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

[0060] Accurately weigh 2.31 mg of genistein standard substance (equivalent to 2.30 mg of genistein) in a 5mL centrifuge tube, dissolve in methanol, and make a stock solution ISS1 with a concentration of 1.0 mg / mL, and use the standard stock solution ISS1 with Dilute with methanol to obtain an internal standard working solution with a concentr...

Embodiment 3

[0070] (1) Preparation of standard working solution

[0071] (1) Preparation of standard working solution:

[0072] Accurately weigh 5.57mg of quetiapine fumarate standard substance (equivalent to 4.83mg of quetiapine mass) in a 15mL centrifuge tube, dissolve with methanol, and prepare stock solution S1 with a quetiapine concentration of 1.0mg / mL. Dilute the standard stock solution S1 with methanol to prepare quetiapine series standard working solutions containing 1.0, 2.0, 3.0, 6.0, 10, 20, and 60 μg / mL concentrations respectively, and store them in a -80°C refrigerator;

[0073] (2) Preparation of internal standard working solution

[0074] Accurately weigh 2.31 mg of genistein standard substance (equivalent to 2.30 mg of genistein) in a 5mL centrifuge tube, dissolve in methanol, and make a stock solution ISS1 with a concentration of 1.0 mg / mL, and use the standard stock solution ISS1 with Dilute with methanol to obtain an internal standard working solution with a concentr...

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Abstract

The invention relates to the technical field of clinical blood concentration monitoring of psychotropic drugs, in particular to an HPLC-DAD method for determinating quetiapine drug concentration of human serum. The invention provides a method for determinating the quetiapine concentration of the serum after a quetiapine drug is taken. The method comprises the following steps: pretreating a human serum sample and performing high-performance liquid chromatography (HPLC-DAD) analysis. The invention establishes the HPLC-DAD method with strong specificity, high sensitivity and high reproducibility.By the method for determinating the quetiapine blood concentration, established for the first time, verification results in aspects of accuracy, precision, specificity, stability and the like meet analytical requirements of the 2015 edition of relevant guiding principles of the Pharmacopoeia of the People's Republic of China (9012) on a biological sample.

Description

technical field [0001] The invention relates to the technical field of clinical blood drug concentration monitoring of psychiatric drugs, in particular to the HPLC-DAD method for measuring the drug concentration of quetiapine in human serum. Background technique [0002] Quetiapine is a new atypical antipsychotic, an antagonist of multiple neurotransmitter receptors in the brain, mainly acting on 5-HT 2 、D 1 、D 2 and D 4 Receptor, it has positive curative effect on schizophrenia, good safety and few adverse reactions. Affected by gene polymorphism, there are large individual differences in the metabolic process in the body, and the blood drug concentration is closely related to the clinical efficacy and adverse reactions. Adjusting the dosage according to the blood drug concentration can ensure the efficacy of the drug and reduce adverse reactions, so as to achieve individual chemical medicine. Therefore, monitoring blood drug concentration in patients is of great signi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王漫漫隋雯雯
Owner 沈阳和合医学检验所有限公司
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