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Levo-fosfomycin dextro-phenethylamine salt and detection method for enantiomer thereof

A technology for enantiomers and detection methods, applied in the field of drug analysis, can solve problems such as affecting drug quality

Active Publication Date: 2017-06-20
JIANGSU SKYRUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, levofosfomycin has a curative effect, and after being separated from the racemate, it is further refined into a product; and levofosfomycin [(+)-cis-(1S,2R)-1,2-epoxy Propyl phosphate] has no effect, and its precursor substance, dexfosfomycin, levophenethylamine salt, is (1S,2R)-(+)-1,2-epoxypropyl phosphate-S-(-)-α -Phenylethylamine, this impurity will cause dexfosfomycin to remain in the drug through subsequent reactions, affecting the quality of the drug

Method used

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  • Levo-fosfomycin dextro-phenethylamine salt and detection method for enantiomer thereof

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Experimental program
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Effect test

Embodiment 1

[0010] Chromatographic conditions:

[0011] High performance liquid chromatography: Agilent high performance liquid chromatography 1260

[0012] Chromatographic column: CHIRALPAK-QNAX (150mm×4.6mm, 5μm) anion exchange chiral column

[0013] Mobile phase: methanol-acetonitrile-acetic acid-ammonium acetate=80:20:2:0.5 (V:V:V:M)

[0014] Column temperature: 35°C

[0015] Flow rate: 1.0ml / min

[0016] Detector temperature: 35°C

[0017] Injection volume: 10μl

[0018] Implementation steps: take an appropriate amount of fosfomycin phenethylamine salt racemate, dissolve it with mobile phase, and make a solution containing about 40 mg of fosfomycin phenethylamine salt racemate in every 1 ml as a system suitability solution. Take 800 mg of levofomycin dexphenethylamine salt, accurately weighed, place in a 10 ml measuring bottle, add mobile phase to dissolve and dilute to the mark, as the test solution. Take 16 mg of dexfosfomycin levophenethylamine salt, accurately weigh it, pla...

Embodiment 2

[0020] Chromatographic conditions:

[0021] High performance liquid chromatography: Agilent high performance liquid chromatography 1260

[0022] Chromatographic column: CHIRALPAK-QNAX (150mm×4.6mm, 5μm) anion exchange chiral column

[0023] Mobile phase: methanol-acetonitrile-acetic acid-ammonium acetate=80:20:1:0.2 (V:V:V:M)

[0024] Column temperature: 30°C

[0025] Flow rate: 1.0ml / min

[0026] Detector temperature: 30°C

[0027] Injection volume: 8μl

[0028] Implementation steps: take an appropriate amount of fosfomycin phenethylamine salt racemate, dissolve it with mobile phase, and make a solution containing about 40 mg of fosfomycin phenethylamine salt racemate in every 1 ml as a system suitability solution. Take 800 mg of levofomycin dexphenethylamine salt, accurately weighed, place in a 10 ml measuring bottle, add mobile phase to dissolve and dilute to the mark, as the test solution. Take 16 mg of dexfosfomycin levophenethylamine salt, accurately weigh it, plac...

Embodiment 3

[0030] Chromatographic conditions:

[0031] High performance liquid chromatography: Agilent high performance liquid chromatography 1260

[0032] Chromatographic column: CHIRALPAK-QNAX (150mm×4.6mm, 5μm) anion exchange chiral column

[0033] Mobile phase: methanol-acetonitrile-acetic acid-triethylamine=80:20:2:0.6 (V:V:V:V)

[0034] Column temperature: 32°C

[0035] Flow rate: 0.8ml / min

[0036] Detector temperature: 32°C

[0037] Injection volume: 5μl

[0038] Implementation steps: take an appropriate amount of fosfomycin phenethylamine salt racemate, dissolve it with mobile phase, and make a solution containing about 40 mg of fosfomycin phenethylamine salt racemate in every 1 ml as a system suitability solution. Take 800 mg of levofomycin dexphenethylamine salt, accurately weighed, place in a 10 ml measuring bottle, add mobile phase to dissolve and dilute to the mark, as the test solution. Take 16 mg of dexfosfomycin levophenethylamine salt, accurately weigh it, place i...

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Abstract

The invention discloses a levo-fosfomycin dextro-phenethylamine salt and a detection method for an enantiomer thereof, and relates to the field of pharmaceutical analysis. The levo-fosfomycin dextro-phenethylamine salt and the enantiomer thereof are analyzed by using a high performance liquid chromatograph, and sample analysis is performed by adopting a negative ion exchange chiral column and a flowing phase of specific components and proportion. The method can be used for easily, rapidly and accurately analyzing and separating the levo-fosfomycin dextro-phenethylamine salt and the enantiomer thereof. The method has the advantages of high reproducibility, high separation degree, stability in detecting samples, and the like.

Description

technical field [0001] The invention relates to a detection method, in particular to a detection method of levofomycin dexphenethylamine salt and its enantiomer, and belongs to the field of drug analysis. Background technique [0002] Fosfomycin (fosfomycin, phosphonomycin) is a new type of broad-spectrum antibiotic produced by Streptomyces isolated from Spanish soil by MERCK Company of the United States and CEP Company of Spain in 1969. It is widely used abroad. In 1993, it was listed as the national essential drug of our country. Fosfomycin has a unique chemical structure and antibacterial mechanism, broad-spectrum, enzyme resistance, high efficiency, and low toxicity. It has small molecular weight, good tissue permeability, wide distribution, high drug concentration in blood and urine, less allergic reaction, no toxicity to audiovisual nerve and kidney, no antagonistic effect and no cross-resistance with other antibiotics. In addition, fosfomycin can inhibit the early s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 燕立波姜向敏金永华李佼佼
Owner JIANGSU SKYRUN PHARMA CO LTD
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