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Method for determining concentration of pregabalin in plasma by liquid chromatography-mass spectrometry

A technology of pregabalin and liquid chromatography-mass spectrometry, which is applied in the determination of drugs and liquid mass spectrometry to determine the concentration of pregabalin in plasma, can solve the problems of pregabalin determination methods and literature reports, and achieve the pretreatment method Simplicity, good peak shape, and high sensitivity

Inactive Publication Date: 2020-04-21
南京立顺康达医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no literature report on the determination method of pregabalin

Method used

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  • Method for determining concentration of pregabalin in plasma by liquid chromatography-mass spectrometry
  • Method for determining concentration of pregabalin in plasma by liquid chromatography-mass spectrometry
  • Method for determining concentration of pregabalin in plasma by liquid chromatography-mass spectrometry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0032] Example: Human K 2 Determination of Pregabalin Concentration in EDTA Plasma

[0033] 1. Experimental materials and analytical equipment

[0034] Pregabalin (analyte): China National Institutes for Food and Drug Control or the same or higher grade standard Pregabalin-d4 (internal standard): Toronto Research Chemicals or the same or higher grade standard

[0035] The reagents used are shown in Table 1 below:

[0036] Table 1 Reagent Details

[0037] Reagent name level manufacturer Methanol HPLC J. T. Baker formic acid ACS Adamas

[0038] Note: Reagents of the same grade or higher can also be used

[0039] The analytical equipment used is shown in Table 2 below:

[0040] Table 2 Details of equipment used

[0041]

[0042]

[0043] The same LC / MS / MS system can also be used.

[0044] 2. Liquid conditions

[0045] 1. Liquid chromatography conditions

[0046]The chromatographic column is Restek Allure PFPP, 5 μm, and the colum...

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PUM

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Abstract

The invention discloses a method for determining the concentration of pregabalin in plasma by liquid chromatography-mass spectrometry, which adopts a liquid chromatography-mass spectrometry system fordetermination and comprises the steps of taking a sample to be detected, adding a certain amount of mixed organic solvent for extraction, separating by using a chromatographic column after pretreatment, and detecting by using a mass spectrometry detector. The method disclosed by the invention is rapid, accurate, high in sensitivity and simple and convenient to operate, and provides a basis for measuring the plasma concentration of pregabalin; and the linear range of a plasma standard curve of the method is 0.05-15[mu]g / mL, the intra-batch precision RSD and the inter-batch precision RSD are both less than + / -15%, and the method is suitable for measuring the concentration of pregabalin in plasma.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a method for measuring medicines, in particular to a method for measuring the concentration of pregabalin in blood plasma by liquid mass spectrometry. Background technique [0002] Neuropathic pain refers to the pain caused by damage or lesions of the nervous system, which is mainly characterized by dull pain, burning, and tingling pain. It is estimated that approximately 1% of the world's population is affected by these diseases. Epilepsy is an abnormal discharge caused by excessive excitability of brain neurons, which is a brain disorder syndrome. According to the statistics of the World Health Organization, the total number of epilepsy patients in the world is as high as more than 50 million. In China alone, the number exceeds 6 million, and the incidence rate is about 5 / 1000. Studies have found that many antiepileptic drugs also have analgesic effect. [0003] Pregabalin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88G01N2030/062G01N2030/8813
Inventor 林明弘
Owner 南京立顺康达医药科技有限公司
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