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Method for determining content of phorone in Nicodil by gas chromatography-mass spectrometry

A technology of nicorandil and GC-MS, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of unfavorable preparation research, high time cost, cumbersome operation, etc., and achieve short analysis time, low cost of use, and easy handling The effect of simple process

Pending Publication Date: 2021-10-26
JIANGSU TASLY DIYI PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The content determination method of nicorandil has reported electrochemical method, spectrophotometry in the literature, and the Japanese Pharmacopoeia (J1P 6) has recorded the nicorandil crude drug, and its content determination method is a non-aqueous titration method, and these methods The operation is cumbersome, the time cost is high, and the efficiency is low, which is not conducive to the research on preparations in actual production

Method used

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  • Method for determining content of phorone in Nicodil by gas chromatography-mass spectrometry
  • Method for determining content of phorone in Nicodil by gas chromatography-mass spectrometry
  • Method for determining content of phorone in Nicodil by gas chromatography-mass spectrometry

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Embodiment 1-5

[0034] Chromatographic conditions

[0035] The chromatographic condition of described gas chromatograph is: injection volume is 1 microliter, and chromatographic column is Agilent DB-624UI, 30m * 0.32mm, ID * 1.8 μ m, carrier gas is high-purity helium; Carrier gas velocity is 1.5ml / min; the split ratio is 20:1; the temperature rise program is to use 140°C as the initial column temperature, keep it for 3 minutes, raise it to 220°C at a rate of 20°C / min, keep it for 5 minutes, continue to heat up to 250°C and keep it for 3 minutes, the interface temperature The temperature is 220°C; the ion source is 123.1 / 83.1 / 55.1 Dwell 50; the ion source temperature is 230°C; the solvent delay time is 3min.

[0036] Reference substance solution preparation

[0037] Weigh about 2 mg of phorone reference substance, weigh it accurately, put it in a 2ml measuring bottle, dissolve it with a diluent and dilute to the mark, shake well, and prepare the reference substance stock solution 1 (1mg / ml);...

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Abstract

The invention discloses a method for determining the content of phorone in Nicodil by gas chromatography-mass spectrometry, which comprises the following steps of: 1, preparing a reference substance solution, precisely weighing a phorone reference substance, putting the phorone reference substance into a volumetric flask, dissolving the phorone reference substance to a scale by using a diluent, and uniformly shaking; 2, preparing a test solution, precisely weighing a dinitrandil raw material medicine, putting the dinitrandil raw material medicine into a volumetric flask, dissolving the dinitrandil raw material medicine to a scale by using a diluent, and uniformly shaking; 3, taking the diluent as a blank sample, and placing the diluent in a volumetric flask; and 4, precisely measuring the test solution and the reference solution, performing sample introduction, performing separation analysis by adopting a gas chromatograph-mass spectrometer, and recording a spectrogram. The detection method provided by the invention is verified by a test, and a result shows that the method is strong in specificity, good in precision and high in accuracy, and can be used for rapidly determining the content of the phorone in the Nicodil.

Description

technical field [0001] The invention relates to a determination method, in particular to a method for determining the content of phorone in nicorandil by gas chromatography-mass chromatography. Background technique [0002] Nicorandil is a potassium channel opener, a coronary vasodilator, which can effectively treat angina pectoris and has been widely used clinically in recent years. The content determination method of nicorandil has reported electrochemical method, spectrophotometry in the literature, and the Japanese Pharmacopoeia (J1P 6) has recorded the nicorandil crude drug, and its content determination method is a non-aqueous titration method, and these methods The operation is cumbersome, the time cost is high, and the efficiency is low, which is not conducive to the research on the preparation in the actual production. Contents of the invention [0003] The main purpose of the present invention is to provide a method for determining the content of phorone in Nico...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/72
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/72G01N2030/042G01N2030/324
Inventor 丁爱忠孔凯丽成芳洪林云张静平
Owner JIANGSU TASLY DIYI PHARMA CO LTD
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