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Method for detecting related substances in fosfomycin sodium by high-performance liquid chromatography

A high-performance liquid chromatography and detection technology of fosfomycin sodium, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of unrecorded and other problems, and achieve the effects of mild detection conditions, simple preparation, and strong specificity

Active Publication Date: 2012-12-26
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the detection methods of its related substances are not included in the legal detection methods of fosfomycin sodium at present. In order to ensure the quality and safety of the drug, it is urgent to establish detection methods to control it.

Method used

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  • Method for detecting related substances in fosfomycin sodium by high-performance liquid chromatography
  • Method for detecting related substances in fosfomycin sodium by high-performance liquid chromatography
  • Method for detecting related substances in fosfomycin sodium by high-performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Chromatographic conditions

[0032] Chromatographic column: Zorbax-NH2 (4.6×250mm, 5μm)

[0033] Detector: RID (Refractive Index Detector)

[0034] Detector temperature: 35°C

[0035] Wherein, the chromatographic column Zorbax-NH2 is an amino-propylsilane bonded silica gel column of Agilent Company.

[0036] Preparation of the mobile phase: Accurately weigh 10.89 g of potassium dihydrogen phosphate, dissolve in 1000 ml of purified water, filter, and sonicate to obtain a 0.08 mol / l potassium dihydrogen phosphate solution.

[0037] (2) Preparation of reference solution

[0038] Dissolve 0.6g fosfomycin sodium standard substance with mobile phase, and dilute to 5.0ml with mobile phase, obtain the reference substance solution that every 1ml contains 0.12g fosfomycin sodium standard substance.

[0039] (3) Refer to the preparation of solution 1

[0040] (a) Wet 0.3 g of the test sample with 60 μl of water, and heat in an oven at 60°C for 24 hours. Dissolve the resi...

Embodiment 2

[0065] (1) Chromatographic conditions

[0066] Chromatographic column: Zorbax-NH2 (4.6×250mm, 5μm)

[0067] Detector: RID (Refractive Index Detector)

[0068] Detector temperature: 30°C

[0069] Wherein, the chromatographic column Zorbax-NH2 is an amino-propylsilane bonded silica gel column of Agilent Company.

[0070] Preparation of mobile phase: Accurately weigh 6.80 g of potassium dihydrogen phosphate, dissolve in 1000 ml of purified water, filter, and sonicate to obtain a 0.05 mol / l potassium dihydrogen phosphate solution.

[0071] (2) Preparation of reference solution

[0072] Dissolve 0.3g fosfomycin sodium standard substance with mobile phase, and dilute to 5.0ml with mobile phase, obtain the reference substance solution that every 1ml contains 0.06g fosfomycin sodium standard substance.

[0073] (3) Refer to the preparation of solution 1

[0074] (a) Wet 0.2 g of the test sample with 30 μl of water, and heat in an oven at 50°C for 30 hours. Dissolve the residue w...

Embodiment 3

[0091] (1) Chromatographic conditions

[0092] Chromatographic column: Zorbax-NH2 (4.6×250mm, 5μm)

[0093] Detector: RID (Refractive Index Detector)

[0094] Detector temperature: 40°C

[0095] Wherein, the chromatographic column Zorbax-NH2 is an amino-propylsilane bonded silica gel column of Agilent Company.

[0096] Preparation of mobile phase: Accurately weigh 16.33 g of potassium dihydrogen phosphate, dissolve in 1000 ml of purified water, filter, and sonicate to obtain a 0.12 mol / l potassium dihydrogen phosphate solution.

[0097] (2) Preparation of reference solution

[0098] Dissolve 1.2g fosfomycin sodium standard substance with mobile phase, and dilute to 5.0ml with mobile phase, obtain the reference substance solution that every 1ml contains 0.24g fosfomycin sodium standard substance.

[0099] (3) Refer to the preparation of solution 1

[0100] (a) Wet 0.4 g of the test sample with 90 μl of water and heat it in an oven at 70°C for 16 hours. Dissolve the residu...

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Abstract

The invention discloses a method for detecting related substances in fosfomycin sodium by a high-performance liquid chromatography applied to the field of substance detection of a compound. The method comprises the following steps: taking a reference solution 1 to inject into a high performance liquid chromatograph; recording a spectrogram, and computing the separation degree of a fosfomycin peak and an impurity A peak, wherein the separation degree is greater than or equal to 1.5; taking the reference solution, sampling in parallel, and injecting into the high performance liquid chromatograph; recording the spectrogram, and computing relative standard deviation of the fosfomycin peak area, wherein the standard deviation is smaller than or equal to 0.85%; taking a test solution and the reference solution 2 to respectively inject into the high performance liquid chromatograph; recording the spectrogram; and computing the peak area of the impurities in the test solution. The method is good in reproducibility of related substance detection in the fosfomycin sodium, high in sensitivity, strong in specificity, accurate in detection, simple to operate, mild in detection condition, wide in application of detection device and apparatus, wide in source of a mobile phase orthophosphate aqueous solution and simple to prepare.

Description

technical field [0001] The invention relates to a method for detecting related substances in fosfomycin sodium by using high performance liquid chromatography in the field of compound substance detection. Background technique [0002] Fosfomycin (Fosfomycin) is a broad-spectrum antibiotic discovered in 1967 by Merck of the United States and CEPA of Spain from Streptomyces in Spanish soil. Its molecular weight is very small and it is a structure different from any other antibiotic. new antibiotics. At present, fosfomycin has been widely used in China, Europe, Japan and other countries and regions, and there are mainly 3 varieties used in clinical practice, namely fosfomycin sodium, fosfomycin calcium and fosfomycin trometamol, among which , the species widely used in China is fosfomycin sodium. Fosfomycin sodium has a broad antibacterial spectrum, few adverse reactions, and is easy to enter the infected tissue. It is one of the first-line drugs for the treatment of mild and...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 冯文宇崔莹周岩吴涛谢丹尤楠唐奎山尹宏娄玉涛周秀峰孟涛刘志清
Owner NORTHEAST PHARMA GRP
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