Determination of gs-441524 content in preparations made of polyethylene glycol and water

Abstract

The invention discloses a method for measuring the content of GS-441524 in preparations made of polyethylene glycol and water. The invention comprises the following steps: a. Preparation of test samples: accurately measure the test preparation of Remdesivir intermediate, and use Acetonitrile / water solution is diluted to be test sample; b: the preparation of standard solution: accurately weigh reference substance, dissolve with acetonitrile / water solution and quantitatively dilute step by step into a series of standard solutions; c: liquid chromatography mass spectrometry method determination: quantitative amount Get series of standard solutions in step b and carry out liquid chromatography mass spectrometry to measure, and calculate standard curve with the peak area in the extracted ion flow diagram of GS-441524; Quantitatively measure the test sample in step a and carry out liquid chromatography mass spectrometry; Avoid The bimodal phenomenon of the sample; the molecules of GS-441524 and polyethylene glycol have good separation; the detection limit of mass spectrometry is better than 0.05μg / mL, and the limit of quantification is better than 0.1μg / mL.

Description

technical field [0001] The invention relates to the field of pharmaceutical analysis, in particular to a method for determining the content of remdesivir intermediate GS-441524 in preparations made of polyethylene glycol and water as solvents. Background technique [0002] Remdesivir intermediate GS-441524 is a small molecule nucleotide analog and is a precursor molecule for the synthesis of pharmacologically active nucleoside triphosphates; GS-441524 can also be called nucleoside triphosphate competitive Inhibitors that exhibit potent antiviral activity against many RNA viruses. [0003] CAS registration number of GS-441524: 1191237-69-0, molecular formula: C12H13N5O4 molecular weight: 291.267; systematic chemical name (2R, 3R, 4S, 5R)-2-(4-aminopyrrolo[2,1-f] [1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrile; the English chemical name is (2R,3R,4S,5R)- 2-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrof...

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Problems solved by technology

[0004] GS-441524 itself has been reported in the literature, and it has a strong inhibitory effect on feline infectious peritonitis (FIP) virus, and the half-maximal effect concentration (EC 50 ) is 0.78 μM; Pharmacologically, GS-441524 acts as an alternative substrate for viral RNA polymerase, causing the termination of viral RNA chain polymerization; whether as a synthetic intermediate or metabolite of remdesivir, or directly as a drug itself, In the field of drug analysis, the content of GS-441524 is required to be accurately determined; at present, domestic and foreign literature has not yet seen relevant reports on the content determination method of remdesivir intermediate GS-441524 in the preparation system of polyethylene glycol and water as solvents

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