Method for measuring content of nitrandil nitrogen oxide in nitrandil raw material medicine
A technology of nicorandil and nitrogen oxides, which is applied in the field of determination of nicorandil nitrogen oxides content, can solve the problems of unfavorable preparation research, high time cost, cumbersome operation, etc., and achieve short analysis time and low use cost , The effect of simple processing
Pending Publication Date: 2021-10-26
JIANGSU TASLY DIYI PHARMA CO LTD
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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
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Embodiment 1-8
[0033] Chromatographic conditions
[0034]
[0035]
[0036] The preparation process of the reference substance stock solution is as follows: accurately weigh 2 mg of the reference substance of nicorandil nitrogen oxide, put it in a 2ml measuring bottle, dissolve it with acetonitrile and dilute to the mark, shake well, and prepare the reference substance stock solution 1; Put 0.125ml reference substance stock solution 1 in a 20ml measuring bottle, dilute to the mark with diluent, shake well, and use it as reference substance stock solution 2; accurately measure 0.1ml reference substance stock solution 2, put it in a 25ml measuring bottle, and use diluent Dilute to the mark and shake well as the reference solution.
[0037] The preparation process of need testing solution is need testing solution: Accurately take 25mg of Nicorandil crude drug, put in 25ml measuring bottle, dissolve and dilute to scale with diluent, shake up.
[0038] Take different batches of the test so...
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The invention discloses a method for measuring the content of nitrandil nitrogen oxide in a nitrandil raw material medicine, which comprises the following steps: step 1, preparing a reference substance solution, namely weighing the nitrandil nitrogen oxide, putting the nitrandil nitrogen oxide into a volumetric flask, dissolving the nitrandil nitrogen oxide with acetonitrile, diluting the nitrandil nitrogen oxide to a scale, and uniformly shaking the nitrandil nitrogen oxide to obtain a reference substance stock solution for later use; step 2, preparing a test solution, precisely weighing a dinitrandil raw material medicine, placing the dinitrandil raw material medicine in a volumetric flask, dissolving and diluting the dinitrandil raw material medicine to a scale by using a diluent, and uniformly shaking; step 3, preparing a blank solution, and marking the diluent in the step 2 as a blank sample; and step 4, precisely measuring the test solution and the reference solution, performing sample introduction, performing separation analysis by adopting a liquid chromatograph-mass spectrometer, and recording a spectrogram. The detection method provided by the invention is verified by a test, and the result shows that the method is strong in specificity, good in precision and high in accuracy, and can be used for rapidly determining the amount of the nitrandil nitrogen oxide in the nitrandil raw material medicine.
Description
technical field [0001] The invention relates to a method for determining, in particular to a method for determining the content of nicorandil nitrogen oxides in a nicorandil crude drug. 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 nicorandil nitrogen oxi...
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IPC IPC(8): G01N30/02G01N30/06G01N30/72
CPCG01N30/02G01N30/06G01N30/72
Inventor 丁爱忠孔凯丽成芳洪林云
Owner JIANGSU TASLY DIYI PHARMA CO LTD