Method for determining high-molecular polymer in cefuroxime axetil tablet

A technology of high molecular polymer and furoctyl ester tablets, which is applied in the field of analysis and can solve the problems of sample decomposition, unstable beta-lactam antibiotic solution, and inability to store for a long time.

Active Publication Date: 2020-11-17
JIANGSU QINGJIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the instability of β-lactam antibiotic solution, it cannot be stored for a long time, and long-term storage will cause sample decomposition
The stability and applicability of the existing methods for the tested items have not yet attracted attention

Method used

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  • Method for determining high-molecular polymer in cefuroxime axetil tablet
  • Method for determining high-molecular polymer in cefuroxime axetil tablet
  • Method for determining high-molecular polymer in cefuroxime axetil tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] The selection of embodiment 1 solvent

[0015] Instruments and reagents

[0016] Instruments: water bath, balance;

[0017] Reagents: N,N-dimethylformamide, methanol, ethanol, n-propanol, isopropanol, n-butanol, n-pentanol, n-hexanol, n-octanol, water.

[0018] Solvent selection:

[0019] Add 10ml of N,N-dimethylformamide, add 20mg of cefuroxime axetil tablet powder, keep warm and shake in a 30°C water bath, the sample can be completely dissolved;

[0020] Methanol 10ml, add 20mg of cefuroxime axetil tablet powder, keep warm and shake in 30℃ water bath, the sample can be completely dissolved;

[0021] Add 10ml of ethanol, add 20mg of cefuroxime axetil tablet powder, keep warm and shake in a 30°C water bath, the sample can be completely dissolved;

[0022] Add 10ml of n-propanol, add 20mg of cefuroxime axetil tablet powder, keep warm and shake in a 30°C water bath, the sample can be completely dissolved;

[0023] Add 10ml of isopropanol, add 20mg of cefuroxime axeti...

Embodiment 2

[0030] The selection of embodiment 2 absorption wavelength

[0031] N, N-dimethylformamide 10ml, add 20mg of cefuroxime axetil tablet powder, with air as a reference, measure the maximum absorption wavelength;

[0032] Methanol 10ml, add the cefuroxime axetil tablet powder of 20mg, take air as reference, measure the maximum absorption wavelength;

[0033] Ethanol 10ml, add 20mg of cefuroxime axetil tablet powder, with air as a reference, measure the maximum absorption wavelength;

[0034] Add 20 mg of cefuroxime axetil tablet powder to 10 ml of n-propanol, and measure the maximum absorption wavelength with air as a reference;

[0035] Isopropanol 10ml, add 20mg of cefuroxime axetil tablet powder, with air as a reference, measure the maximum absorption wavelength;

[0036] 10ml of n-butanol, add 20mg of cefuroxime axetil tablet powder, with air as a reference, measure the maximum absorption wavelength;

[0037] 10ml of n-amyl alcohol was added to 20mg of cefuroxime axetil po...

Embodiment 3

[0041] The test of embodiment 3 solution stability

[0042] Detection wavelength: 280nm

[0043] Column temperature: 30°C

[0044] Injection volume: 20µl

[0045] Flow rate: 0.33ml / min

[0046] Mobile phase: 0.03 mol / L lithium bromide in N,N-dimethylformamide

[0047] Chromatographic column: TSKgelG2000Hhr (7.8mml.D.×30cm)

[0048] Sample Preparation:

[0049] N,N-Dimethylformamide 10ml, add 20mg of cefuroxime axetil tablet powder;

[0050] Methanol 10ml, add 20mg of cefuroxime axetil tablet powder;

[0051] 10ml of ethanol, add 20mg of cefuroxime axetil tablet powder;

[0052] 10ml of n-propanol, add 20mg of cefuroxime axetil tablet powder;

[0053] 10ml of isopropanol, add 20mg of cefuroxime axetil tablet powder;

[0054] 10ml of n-butanol, add 20mg of cefuroxime axetil tablet powder;

[0055] 10ml of n-amyl alcohol, add 20mg of cefuroxime axetil tablet powder;

[0056] 10ml of n-hexanol, add 20mg of cefuroxime axetil tablet powder;

[0057] 10ml of n-octanol, ad...

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Abstract

The invention discloses a method for determining a high-molecular polymer in a cefuroxime axetil tablet, which comprises the following steps: chromatographic conditions comprise a high-performance gelchromatographic column, a detector is UV, and a mobile phase is an N, Ndimethylformamide solution of 0.03 mol / L lithium halide containing 25-35% of monohydric alcohols with the number of carbon atomsbeing 38. The method provided by the invention has good solution stability, can effectively prevent degradation of cefuroxime axetil to-be-detected components, and ensures the stability of a sample,so that high-molecular polymers in the cefuroxime axetil tablets can be more accurately controlled, the product quality is ensured, anaphylactic reactions caused by the polymers are prevented, and safe medication of patients is better ensured.

Description

technical field [0001] The invention relates to the technical field of analysis, in particular to a method for detecting high molecular weight polymers in cefuroxime axetil tablets. Background technique [0002] Cefuroxime axetil is a β-lactam antibiotic and is one of the drugs commonly used in clinic. The most common clinical adverse reaction is anaphylaxis. The current research results reveal that the allergens that trigger allergic reactions are not the antibiotics themselves, but the high molecular polymers in them. Therefore, the pharmaceutical industry in various countries conducts research on the high molecular polymers in them. In order to pursue better detection results, chromatographic columns and their fillers for the separation of high molecular polymers in β-lactam antibiotics are emerging. However, people's attention is mainly focused on the separation effect of the chromatographic column, peak shape tailing, column packing repeatability, analysis time and so ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8634
Inventor 王崇益陈加罡黄伟周晶晶隽海龙
Owner JIANGSU QINGJIANG PHARMA
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