Tetrabutylammonium hydrogen sulfate buffer salt system for liquid chromatogram detection

A technology of tetrabutylammonium bisulfate and buffer salt, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of low utilization rate of instruments at night, inability to analyze continuously at night, and inability to prepare too much buffer salt, etc.

Active Publication Date: 2017-09-19
方达医药技术(上海)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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 pharmace

Method used

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  • Tetrabutylammonium hydrogen sulfate buffer salt system for liquid chromatogram detection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation and stability observation of embodiment 1 mobile phase

[0020] 1. Reagent source:

[0021] Water, water for chromatography, self-made;

[0022] Tetrabutylammonium bisulfate, analytically pure, Shanghai Junrui Biotechnology Co., Ltd.;

[0023] Potassium dihydrogen phosphate, analytically pure, Shanghai Junrui Biotechnology Co., Ltd.;

[0024] Phosphoric acid, content 85%, analytically pure, Nanjing Saihongrui Biotechnology Co., Ltd.;

[0025] Dipotassium EDTA, analytically pure, Beijing Baierdi Biotechnology Co., Ltd.

[0026] 2. Preparation method

[0027] Buffer system of the present invention: Weigh 0.5 g of tetrabutylammonium hydrogen sulfate, 1 g of potassium dihydrogen phosphate, 2 mL of phosphoric acid with a content of 85%, 50 mg of dipotassium ethylenediamine tetraacetate, dissolve them in 500 mL of water, dilute with water to 1 L .

[0028] Contrast buffer system: According to the conventional method, weigh 0.5 g of tetrabutylammonium hydroge...

Embodiment 2

[0031] Example 2 Take Moxifloxacin Hydrochloride Injection (20mL: 400mg) as an example to investigate the effect of tetrabutylammonium bisulfate buffered salt system placed at room temperature for 24 hours and the newly configured tetrabutylammonium bisulfate buffered salt system on moxifloxacin, Differences in the chromatographic behavior of N-methyl impurities, impurity A, impurity B, impurity C, impurity D, and impurity E on reversed-phase chromatographic columns

[0032] 1. Preparation of test solution

[0033] Moxifloxacin hydrochloride injection and N-methyl impurity, impurity A, impurity B, impurity C, impurity D, impurity E standard were prepared according to conventional methods to contain 1 mg of moxifloxacin and N-methyl impurity, impurity A , B, C, D, E each 1μg of the test solution as the test solution.

[0034] 2. HPLC analysis method

[0035] Chromatographic column: Agilent Eclipse Plus Phenyl-Hexyl, 4.6mm×150mm, 5μm;

[0036] Detection wavelength: 293nm;

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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...

Claims

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Application Information

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IPC IPC(8): G01N30/06
CPCG01N30/06
Inventor 陈云温思羽王斌
Owner 方达医药技术(上海)有限公司
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