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HPLC detection method for high-molecular impurities in cefepime and preparation thereof

A cefepime and detection method technology, which is applied in the field of pharmaceutical preparation and detection, can solve the problems of polymer impurity control, etc., and achieve the effects of high sensitivity, strong specificity, and improved solubility

Pending Publication Date: 2021-08-06
TIANSHENG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current domestic and international pharmacopoeia quality standards for cefepime and its preparations do not control its polymer impurities.

Method used

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  • HPLC detection method for high-molecular impurities in cefepime and preparation thereof
  • HPLC detection method for high-molecular impurities in cefepime and preparation thereof
  • HPLC detection method for high-molecular impurities in cefepime and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The instruments and setting conditions adopted in this embodiment are as follows:

[0028] High performance liquid chromatography: Shimadzu LC-20AT;

[0029] Chromatographic column: TSK-GEL G2000Wxl, 7.8mm×30cm×5μm;

[0030] Flow rate of mobile phase: 0.6mL / min;

[0031] Detection wavelength: 254nm;

[0032] Column temperature: 25°C;

[0033] Injection volume: 20uL;

[0034] Mobile phase: The concentration of 0.005mol / L phosphate buffer and acetonitrile is configured as the mobile phase according to the volume ratio of 90:10; wherein, the concentration of 0.005mol / L phosphate buffer is prepared in the following way: the concentration of 0.005mol / L disodium hydrogen phosphate solution and concentration 0.005mol / L sodium dihydrogen phosphate solution are prepared by mixing at a volume ratio of 50:50.

[0035] Experimental steps:

[0036] Step 1: Solution preparation

[0037] System adaptability solution: take an appropriate amount of this product, accurately weigh...

Embodiment 2

[0042] The instruments and setting conditions adopted in this embodiment are as follows

[0043] High performance liquid chromatography: Shimadzu LC-20AT;

[0044] Chromatographic column: TSK-GEL G2000Wxl, 7.8mm×30cm×5μm;

[0045] Flow rate of mobile phase: 0.6mL / min;

[0046] Detection wavelength: 254nm;

[0047] Column temperature: 25°C;

[0048] Injection volume: 20uL;

[0049] Mobile phase: The concentration of 0.005mol / L phosphate buffer and acetonitrile is configured as the mobile phase according to the volume ratio of 87.5:12.5; wherein, the concentration of 0.005mol / L phosphate buffer is prepared by the following method: the concentration of 0.005mol / L disodium hydrogen phosphate solution and concentration 0.005mol / L sodium dihydrogen phosphate solution are prepared by mixing at a volume ratio of 50:50.

[0050] Experimental steps:

[0051] Step 1: Solution preparation

[0052] System adaptability solution: take an appropriate amount of this product, accurately...

Embodiment 3

[0056] The instrument and setting conditions adopted in this embodiment:

[0057] High performance liquid chromatography: Shimadzu LC-20AT

[0058] Chromatographic column: TSK-GEL G2000Wxl, 7.8mm×30cm×5μm;

[0059] Flow rate of mobile phase: 0.6mL / min;

[0060] Detection wavelength: 254nm;

[0061] Column temperature: 25°C;

[0062] Injection volume: 20uL;

[0063] Mobile phase: The concentration of 0.005mol / L phosphate buffer and acetonitrile is configured as the mobile phase according to the volume ratio of 92.5:7.5; wherein, the concentration of 0.005mol / L phosphate buffer is prepared in the following way: the concentration of 0.005mol / L disodium hydrogen phosphate solution and concentration 0.005mol / L sodium dihydrogen phosphate solution are prepared by mixing at a volume ratio of 50:50.

[0064] Experimental steps:

[0065] Step 1: Solution preparation

[0066] System adaptability solution: take an appropriate amount of this product, accurately weigh it, add water t...

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Abstract

The invention discloses an HPLC detection method for high-molecular impurities in cefepime and a preparation thereof. The method comprises the steps of separating and measuring polymer impurities in the cefepime and the preparation thereof by using a high performance liquid chromatograph and an isocratic elution method, wherein a chromatographic column with the detection wavelength of 254 + / -2nm takes globular protein chromatographic hydrophilic silica gel as a filler, and a mixed solution consisting of a phosphate buffer solution with the concentration of 0.005 mol / L and the volume percentage of 87.5 to 92.5% and an organic phase with the volume percentage of 7.5 to 12.5% is used as a mobile phase. According to the method, the quality of the high-molecular impurities in cefepime and the preparation thereof can be controlled, and the product quality and medication safety are guaranteed.

Description

technical field [0001] The invention relates to the technical field of medicine preparation and detection, in particular to an HPLC detection method for polymer impurities in cefepime and its preparations. Background technique [0002] Cefepime is a broad-spectrum fourth-generation cephalosporin that achieves bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. In vitro tests have shown that this product has effects on both Gram-positive and Gram-negative bacteria. This product has a low affinity to the β-lactamase encoded by the bacterial chromosome, can be highly resistant to the hydrolysis of most β-lactamases, and can quickly penetrate into the cells of Gram-negative bacteria. In bacterial cells, its target molecule is penicillin-binding protein (PBP). Cefepime hydrochloride for injection is a sterile powder for injection, which is a preparation prepared by aseptically mixing cefepime hydrochloride and L-arginine in a certain proportion. The che...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/36G01N30/32G01N30/54
CPCG01N30/02G01N30/34G01N30/36G01N30/32G01N30/54G01N2030/324
Inventor 刘爽刘明莉唐琴张薇王婷婷郭彬谈宗华吴统选王晓
Owner TIANSHENG PHARMA GROUP
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