Tetrabutylammonium hydrogen sulfate buffer salt system for liquid chromatogram detection

Abstract

The invention discloses a tetrabutylammonium hydrogen sulfate buffer salt system for liquid chromatogram detection. A solvent is water, and a solute comprises tetrabutylammonium hydrogen sulfate and a buffer ion pair; the buffer ion pair is composed of monopotassium phosphate and phosphoric acid; and the solute also comprises a complexing agent which is optimized from dipotassium ethylene diamine tetraacetate. The tetrabutylammonium hydrogen sulfate buffer salt system provided by the invention is stable within 24h and is free of a turbid phenomenon. Taking moxifloxacin hydrochloride related substance analysis as an example, the chromatographic behaviors of the tetrabutylammonium hydrogen sulfate buffer system placed for 24h at room temperature and a newly prepared tetrabutylammonium hydrogen sulfate buffer system on a reversed phase column to moxifloxacin, N-methyl impurities, an impurity A, an impurity B, an impurity C, an impurity D and an impurity E are substantially resistant.

Description

technical field [0001] The invention belongs to the field of liquid phase detection, in particular to a tetrabutylammonium bisulfate buffer salt system for liquid phase detection. Background technique [0002] Tetrabutylammonium bisulfate buffer salt system is often used as aqueous mobile phase in reversed-phase liquid chromatography detection, and can often produce excellent separation effects for some compound pairs with special structures and difficult to separate. [0003] Taking moxifloxacin hydrochloride injection as an example, the main related substances include: N-methyl impurity, impurity A, impurity B, impurity C, impurity D, and impurity E. The analytical method of the related substance that Chinese Pharmacopoeia, European Pharmacopoeia and American Pharmacopoeia provide is reversed-phase liquid chromatography, is filler with phenyl bonded silica gel, and mobile phase is acetonitrile-salt solution (get tetrabutylammonium bisulfate 0.5g, Potassium dihydrogen phos...

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Problems solved by technology

[0005] (1) Do not prepare too much buffer salt at one time, at least twice a working day, and the preparation of mobile phase is a relatively cumbersome matter, especially this kind of buffer salt, which needs to be filtered with a 0.22μm filter membrane, and it needs to be prepared every time. Clean the suction filtration instrument, and then clean it after suction filtration, which is time-consuming and labor-intensive;

[0006] (2) It cannot be analyzed continuously at night; technicians in the field of pharmaceutical analysis know that for the sake of project progress, liquid chromatographs usually work 24 hours a day, and the samples and mobile phases to be analyzed are usually prepared and set up before leaving get off work Instrument analysis sequence, automatic analysis, which can significantly improve work efficiency; but because the tetrabutylammonium bisulfate buffer salt system should not be used for more than 6 hours, it cannot continue to run at night, and the utilization rate of the instrument at night is low

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