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Sensitive and rapid method for analyzing concentration of sufentanil in plasma suitable for pharmacokinetic research

A concentration analysis and pharmacokinetic technology, applied in the field of sufentanil concentration analysis, which can solve the problems of long chromatographic separation time and reduced instrument analysis throughput.

Inactive Publication Date: 2021-05-11
苏州海科医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to meet the simultaneous monitoring of multiple drugs with different polarities, chromatography often uses gradient elution and requires a long chromatographic separation time, which reduces the throughput of instrument analysis

Method used

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  • Sensitive and rapid method for analyzing concentration of sufentanil in plasma suitable for pharmacokinetic research
  • Sensitive and rapid method for analyzing concentration of sufentanil in plasma suitable for pharmacokinetic research
  • Sensitive and rapid method for analyzing concentration of sufentanil in plasma suitable for pharmacokinetic research

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Experimental program
Comparison scheme
Effect test

Embodiment

[0025] Such as Figure 1 to Figure 2 , a method for sensitive and rapid plasma sufentanil concentration analysis suitable for pharmacokinetic studies, comprising the following steps:

[0026] Step 1: Plasma sample pretreatment, add plasma sample and internal standard solution to a 96-well plate, add methanol, vortex, centrifuge, take out the supernatant, add ultrapure water, vortex mix, inject 10.0 μL, and perform LC- MS / MS analysis;

[0027] Step 2: chromatographic separation;

[0028] Chromatographic conditions, chromatographic column: Venusil ASB-C18 column, 3μm, 50×4.6mm; column temperature: 40°C; mobile phase A is 2mM ammonium acetate aqueous solution containing 0.2% formic acid, mobile phase B is acetonitrile containing 0.1% formic acid, Use the A:B equal degree elution with a volume ratio of 40:60; the temperature of the autosampler is 4°C, and the flow rate of the mobile phase is: 0.60mL / min;

[0029] Step 3: mass spectrometry detection;

[0030] Mass spectrometry ...

Embodiment 1

[0033] Abbreviation

[0034]

[0035] 1 material

[0036] 1.1 Instrument

[0037] Shimadzu Corporation LC-30AD ultra-high performance liquid chromatography system and AB Sciex 6500 triple quadrupole tandem mass spectrometer, equipped with ESI source.

[0038] Analyst 1.6.3 software was used for data processing.

[0039] Beijing Sartorius Instrument Co., Ltd. CP225D analytical balance.

[0040] Japan Hitachi company CT15RE centrifuge.

[0041] 1.2 Standards and reagents

[0042] Sufentanil citrate (content 99.2%); Fentanyl citrate (content 100%); Methanol and acetonitrile were purchased from Sigma Company in the United States; formic acid was purchased from TCI Company in Japan; ammonium acetate was purchased from ROE Company in the United States; Ionized water was prepared by a Millipore water purifier. All the above reagents were chromatographically pure.

[0043] 2 methods

[0044] 2.1 Preparation of solution

[0045] Standard curve sample preparation

[0046] W...

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Abstract

The invention relates to a sensitive and rapid method for analyzing the concentration of sufentanil in plasma suitable for pharmacokinetic research. The method comprises the following steps: 1, pre-treating a plasma sample; 2, performing chromatographic separation; and 3, performing mass spectrum detection. The detection method disclosed by the invention is high in sensitivity, simple in pretreatment operation, small in sample dosage, high in instrument analysis flux and suitable for clinical pharmacokinetic research of sufentanil patches.

Description

technical field [0001] The invention relates to a sensitive and rapid plasma sufentanil concentration analysis method suitable for pharmacokinetic research. Background technique [0002] Sufentanil is a potent μ-receptor agonist that can easily pass through the nerve cell membrane and the blood-brain barrier. It is the drug with the strongest analgesic effect among fentanyl drugs. Sufentanil injection was approved by the US FDA in 1984. Since sufentanil is very potent and can be achieved with a relatively low concentration of plasma drug, the analytical methods used in clinical drug monitoring usually need to have high sensitivity. Sufentanil patch is an improved new drug, which is currently in the process of clinical research. Through the way of body surface administration, the toxic and side effects of the drug can be reduced, and the action time can be prolonged, which has an optimistic prospect of clinical application. However, the local effect of topical administrati...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 杨勇张先锋陈鑫刘旭凌傅瑶钟勘姜金方周茂金
Owner 苏州海科医药技术有限公司
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