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

A technique of tadalafil and liquid mass spectrometry, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of large matrix interference, complex composition, difficult to obtain samples, etc., and achieve high sensitivity, strong specificity, predictive The effect of simple processing method

Inactive Publication Date: 2020-03-27
徐州立兴佳正医药科技有限公司
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  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The composition of tadalafil biological samples is complex, the matrix interferes greatly, and the samples are difficult to obtain and the amount is small, and the concentration of the analyte is usually very low. Therefore, the requirements for the separation and analysis technology of biological samples are getting higher and higher, and it is urgent to establish A high-sensitivity, high-precision, high-selectivity rapid content determination method for tadalafil

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0031] Example: Human K 2 Determination of Tadalafil Concentration in EDTA Plasma

[0032] 1. Experimental materials and analytical equipment

[0033] Tadalafil (analyte): U.S. Pharmacopeial Convention or equivalent or higher grade standard

[0034] Tadalafil-d3 (internal standard): SimSon Pharma or the same or higher grade standard

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

[0036] Table 1 Reagent Details

[0037]

[0038]

[0039] Note: Reagents of the same grade or higher can also be used

[0040] The analytical equipment used is shown in Table 2 below:

[0041] Table 2 Details of equipment used

[0042] components model manufacturer Binary pump (binary pump) AC Pump AB SCIEX Degasser Degasser AB SCIEX Column oven AC Columnoven AB SCIEX Autosampler (auto sampler) AC Autosampler AB SCIEX Sample rack Rack Changer AB SCIEX Mass spectrometer QTRAP TM 6500+

AB SCIEX Data proces...

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Abstract

The invention discloses a method for determining the concentration of tadalafil 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, performing separating by usinga chromatographic column, and performing 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 blood concentration of tadalafil; according to the method, the linear range of a plasma standard curve is 1-600ng / mL, the intra-batch precision RSD and theinter-batch precision RSD are both less than + / -15%, and the method is suitable for measuring the concentration of tadalafil 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 tadalafil in blood plasma by liquid mass spectrometry. Background technique [0002] The chemical name of Tadalafil is: (6R-12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12 , 12a-hexahydropyrazino[1',2'-1,6]-pyrido[3,4-b]indole-1,4-dione, is a cyclic guanosine monophosphate (cGMP)-specific phosphate A selective reversible inhibitor of diesterase 5 (PDE5), initially developed by GlaxoSmithKline (GSK), and subsequently transferred to ICOS, and later jointly developed by ICOS and Eli Lilly (EliLillv). Approved by the FDA in 2003, it was listed in the United States as a drug for the treatment of male erectile dysfunction (MED). When sexual stimulation leads to the local release of nitric oxide, PDE5 is inhibited by tadalafil, which increases the level of cGMP in the corpus cavernosum of the penis, which leads to relaxation of smooth...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06G01N30/34G01N30/72
CPCG01N30/06G01N30/34G01N30/72G01N30/88G01N2030/045G01N2030/062G01N2030/8822G01N2030/884
Inventor 林明弘
Owner 徐州立兴佳正医药科技有限公司
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