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HPLC detection method for polymer impurities in flucloxacillin and preparation thereof

A flucloxacillin 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, good separation, and strong specificity

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 pharmacopoeia quality standards for flucloxacillin and its preparations at home and abroad do not control its polymer impurities.

Method used

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  • HPLC detection method for polymer impurities in flucloxacillin and preparation thereof
  • HPLC detection method for polymer impurities in flucloxacillin and preparation thereof
  • HPLC detection method for polymer impurities in flucloxacillin and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The instruments and setting conditions adopted in this embodiment are as follows:

[0030] High performance liquid chromatography: Shimadzu LC-20AT;

[0031] Chromatographic column: TSK-GEL G2000Wxl, 7.8mm×30cm×5μm;

[0032] Flow rate of mobile phase: 0.6mL / min;

[0033] Detection wavelength: 254nm;

[0034] Column temperature: 25°C;

[0035] Injection volume: 20uL;

[0036] Wherein the mobile phase: the concentration is 0.01mol / L phosphate buffer solution and acetonitrile according to the mass fraction ratio 9:1 is configured as the mobile phase, wherein the concentration is 0.01mol / L phosphate buffer solution is prepared by the following method: the concentration is 0.01mol / L disodium hydrogen phosphate solution and concentration 0.01mol / L sodium dihydrogen phosphate solution are mixed and prepared at a mass ratio of 61:39.

[0037] Experimental steps:

[0038] Step 1: Solution preparation

[0039] System adaptability solution: Take an appropriate amount of th...

Embodiment 2

[0046] The instruments and setting conditions adopted in this embodiment are as follows

[0047] High performance liquid chromatography: Shimadzu LC-20AT;

[0048] Chromatographic column: TSK-GEL G2000Wxl, 7.8mm×30cm×5μm;

[0049] Flow rate of mobile phase: 0.6mL / min;

[0050] Detection wavelength: 254nm;

[0051] Column temperature: 25°C;

[0052]Injection volume: 20uL;

[0053] Wherein the mobile phase: the concentration is 0.01mol / L phosphate buffer solution and acetonitrile according to the mass fraction ratio 87.5:12.5 is configured as the mobile phase, wherein the concentration is 0.01mol / L phosphate buffer solution is prepared in the following way: the concentration is 0.01mol / L disodium hydrogen phosphate solution and concentration 0.01mol / L sodium dihydrogen phosphate solution are mixed and prepared at a mass ratio of 61:39.

[0054] Experimental steps:

[0055] Step 1: Solution preparation

[0056] System adaptability solution: Take an appropriate amount of t...

Embodiment 3

[0063] The instrument and setting conditions adopted in this embodiment:

[0064] High performance liquid chromatography: Shimadzu LC-20AT

[0065] Chromatographic column: TSK-GEL G2000Wxl, 7.8mm×30cm×5μm;

[0066] Flow rate of mobile phase: 0.6mL / min;

[0067] Detection wavelength: 254nm;

[0068] Column temperature: 25°C;

[0069] Injection volume: 20uL;

[0070] Wherein the mobile phase: a concentration of 0.01mol / L phosphate buffer and acetonitrile is configured as the mobile phase according to the mass fraction ratio of 92.5:7.5, wherein the concentration of 0.01mol / L phosphate buffer is prepared in the following way: the concentration of 0.01mol / L disodium hydrogen phosphate solution and concentration 0.01mol / L sodium dihydrogen phosphate solution are mixed and prepared at a mass ratio of 61:39.

[0071] Experimental steps:

[0072] Step 1: Solution preparation

[0073] System adaptability solution: Take an appropriate amount of this product, accurately weigh it,...

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Abstract

The invention discloses an HPLC detection method for polymer impurities in flucloxacillin and a preparation thereof. The method comprises the steps of separating and determining the polymer impurities in flucloxacillin 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 nm takes globular protein chromatographic hydrophilic silica gel as a filler, and a mixed solution consisting of a phosphate buffer solution with the concentration of 0.01 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 invention, quality control can be performed on the flucloxacillin polymer impurities so as to ensure the product quality and the medication safety.

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 flucloxacillin and its preparations. Background technique [0002] Flucloxacillin sodium is a semi-synthetic penicillinase-resistant penicillin. Its mechanism of action is similar to that of penicillin G. It binds to penicillin-binding proteins (PBPs) on the cell membrane, inhibits the biosynthesis of bacterial cell walls, and causes the bacteria to swell and rupture, thereby exerting a bactericidal effect. This drug is a bactericidal drug during the breeding period. It has good stability to penicillinase and has a strong bactericidal effect on penicillinase-resistant Staphylococcus aureus, but its antibacterial effect on penicillin-sensitized staphylococcus and various streptococci is weaker than that of penicillin. Flucloxacillin sodium has good antibacterial activity against penicillinase-producing ...

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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