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

A technology of lacosamide and LC/MS, applied in the field of medicine, can solve the problems of speed, precision, sensitivity, selectivity, etc. to be improved, and achieve the effects of simple pretreatment method, rapid method and simple operation.

Inactive Publication Date: 2021-04-09
徐州立顺康达医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most clinical factors did not influence retention rates, withdrawals were not due to occurrence of adverse events but often due to futility
[0004] At present, the speed, precision, sensitivity and selectivity of the existing methods for the determination of lacosamide need to be improved

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

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

[0033] 1. Experimental materials and analytical equipment Lacosamide (analyte): TLC Pharmaceutical Standards or the same or higher standard Lacosamide-d6 (internal standard): TLC Pharmaceutical Standards or the same or higher standard The reagents used in the product are shown in Table 1 below:

[0034] Table 1 Reagent Details

[0035] Reagent name level manufacturer Acetonitrile (ACN) HPLC J. T. Baker Ammonium acetate (CH 3 COONH 4 )

HPLC J. T. Baker Methanol (MeOH) HPLC J. T. Baker

[0036] Note: Reagents of the same grade or higher can also be used

[0037] The analytical equipment used is shown in Table 2 below:

[0038] Table 2 Details of equipment used

[0039] components model manufacturer Binary pump (binary pump) AC Pump AB SCIEX Degasser Degasser AB SCIEX Column oven AC Column oven AB SCI...

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Abstract

The invention discloses a method for determining the concentration of lacosamide in blood plasma by liquid chromatography-mass spectrometry, which adopts a liquid chromatography-mass spectrometry system for determination, and comprises the following steps: taking a sample to be detected, adding a certain amount of mixed organic solvent for extraction and pretreatment, separating by a chromatographic column, and detecting by 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 determining the blood concentration of lacosamide; and according to the method, the linear range of the plasma standard curve is 100-15000 ng / mL, the intra-batch precision RSD and the inter-batch precision RSD are both smaller than + / -15%, and the method is suitable for measuring the concentration of lacosamide in plasma.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a method for determining the concentration of lacosamide in blood plasma by liquid mass spectrometry. Background technique [0002] At present, more than 200,000 epilepsy patients worldwide have used lacosamide. Lacosamide is not currently approved for the treatment of epilepsy in Japan or China. In 2012, UCB announced the initiation of phase III clinical trials of lacosamide in Japan and China, the purpose of which was to study the effectiveness and safety of lacosamide as an adjuvant therapy for adult patients with partial onset epilepsy. [0003] The antiepileptic effect of lacosamide is considered to modulate the slow inactivation of sodium channels, and its efficacy and tolerability have been shown in some randomized controlled trials. A single-center, large-scale cohort study found that the retention rate of continuous administration of lacosamide tablets in the treatme...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88
Inventor 范志鸿
Owner 徐州立顺康达医药科技有限公司
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