Detection method of cis-trans isomer in cis-propenyl phosphonic acid and related impurity thereof

A technology of isomerization of cis-acrylophosphate and cis-trans isomerization, which is applied in measuring devices, instruments, scientific instruments, etc., and can solve problems such as no related reports

Active Publication Date: 2012-06-20
NORTHEAST PHARMA GRP
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Problems solved by technology

At present, there is no relevant report on the detection method of cis-trans isomers and related impurities in cis-acrylophosphate

Method used

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Embodiment Construction

[0014] The following examples will help to understand the present invention, but these examples are only for illustrating the present invention, and the present invention is not limited to these contents.

[0015] A detection method for cis-trans isomers and related impurities thereof in cis-acrylphosphoric acid, said method comprising the steps of:

[0016] (1) Chromatographic conditions:

[0017] Chromatographic column: C-18 column, 4.6mm×250mm×5.0μm; flow rate 1.0ml / min; UV detector, detection wavelength 225nm, injection volume 10μl;

[0018] Mobile phase: 50mmol / L dipotassium hydrogen phosphate aqueous solution-methanol;

[0019] (2) Preparation of test solution: take 0.1 μl of test product, dissolve and dilute to 25 ml with mobile phase, and filter;

[0020] (3) Get the test solution, inject 10 microliters of samples, and record the spectrum. The retention time of cis-acrylphosphate is 12.3min, the relative retention value of its cis-trans isomers is 1.15, and the relat...

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Abstract

A detection method of cis-trans isomers in cis-propenyl phosphonic acid and related impurities thereof is applicable to the field of pharmaceutical analysis, and the method comprises the following steps and conditions: the chromatographic conditions are that the chromatographic column is a C-18 column of 4.6 mm*250 mm*5.0 microns; the flow velocity is 1.0 ml / min; an ultraviolet detector has a detection wavelength of 225 nm and a sample size of 10 microliters; the mobile phase is 50 mmol / L dipotassium hydrogen phosphate aqueous solution-methanol; preparing a test solution by dissolving 0.1 microliters of test samples in the mobile phase, diluting to 25 ml, and filtering; introducing 10 microliters of the test solution, recording a spectrum, wherein the retention time for cis-propenyl phosphonic acid is 12.3 min, the relative retention value of its cis-trans isomers is 1.15, and the relative retention value of propadiene phosphonic acid is 0.38, and calculating the contents of various impurities by an area normalization method; in the mobile phase, the 50 mmol / L dipotassium hydrogen phosphate aqueous solution contains 2% of tetrabutylammonium hydroxide aqueous solutions; the concentration of the tetrabutylammonium hydroxide aqueous solution is 55%. According to the invention, the method is used for the detection of cis-trans isomers in cis-propenyl phosphonic acid and related impurities thereof, and the repeatability, the sensitivity, and the accuracy all meet the requirements.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for detecting cis-trans isomers and related impurities in cis-acrylophosphate. Background technique [0002] At present, fosfomycin 1,2-epoxypropyl phosphate disodium salt, a free acid, was originally isolated from Streptomyces fradicle, which is effective against Gram-positive and negative bacteria, and its mechanism of action is to inhibit the synthesis of bacterial cell walls cause bacterial death. Fosfomycin can be combined with a bacterial cell wall synthesizing enzyme to hinder the first step in the synthesis of cell walls by bacteria using related substances, thereby playing a bactericidal role. Fosfomycin has a wide antibacterial spectrum and is mainly used for Staphylococcus aureus and Escherichia coli bacteria, Lebsiella pneumoniae, Bacillus aerogenes, Serratia, Shigella, Pseudomonas aeruginosa and other sensitive bacteria caused respiratory tract, urinary tract, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 冯文宇苏贵弟孟涛娄玉涛金玉坤尤楠邓暤周秀峰唐奎山
Owner NORTHEAST PHARMA GRP
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