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Liquid chromatography method for determining clavulanic acid related substances in amoxicillin and clavulanic acid potassium pharmaceutical composition

A technology of amoxicillin-clavulanate potassium and clavulanic acid, which is applied in the field of drug impurity analysis and detection, can solve problems such as interference, and achieve the effects of improving accuracy, facilitating product quality control, and simple and easy cost analysis

Active Publication Date: 2020-06-05
JIANGSU SIMCERE PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disclosed determination method of related substances of clavulanic acid is HPLC method (see Chinese Pharmacopoeia 2015 Edition Part Two), and it is found through research that during the experimental operation, the above method is easily affected by the main component amoxicillin and other impurities in the pharmaceutical composition. interference

Method used

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  • Liquid chromatography method for determining clavulanic acid related substances in amoxicillin and clavulanic acid potassium pharmaceutical composition
  • Liquid chromatography method for determining clavulanic acid related substances in amoxicillin and clavulanic acid potassium pharmaceutical composition
  • Liquid chromatography method for determining clavulanic acid related substances in amoxicillin and clavulanic acid potassium pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Experimental equipment and conditions:

[0065] Agilent high performance liquid chromatography; DAD detector; Waters Atlantis T3, 5μm, 250×4.6mm as the separation column.

[0066] Detection conditions:

[0067] Flow rate: 1.0ml / min; Detection wavelength: 214nm; Column temperature: 30°C; 0.03mol / L ammonium acetate aqueous solution (adjust the pH value to 5.70 with glacial acetic acid)-acetonitrile (80:20), perform linear gradient elution according to Table 1:

[0068] Table 1 Gradient elution program

[0069]

[0070] Experimental procedure: 0.03mol / L ammonium acetate aqueous solution (adjust pH value to 5.70 with glacial acetic acid) as mobile phase A, use 0.03mol / L ammonium acetate aqueous solution (adjust pH value to 5.70 with glacial acetic acid)-acetonitrile (80:20) It is the mobile phase B, eluted according to the gradient in Table 1, the flow rate is 1.0ml / min, the detection wavelength is 214nm, and the column temperature is 30°C; take clavulanic acid impuri...

Embodiment 2

[0073] Experimental equipment and conditions:

[0074] Agilent high performance liquid chromatography; DAD detector; Waters Atlantis T3, 5μm, 250×4.6mm as the separation column.

[0075] Detection conditions:

[0076] Flow rate: 0.8ml / min; Detection wavelength: 214nm; Column temperature: 30°C; 0.05mol / L ammonium acetate aqueous solution (adjust the pH value to 5.70 with glacial acetic acid)-acetonitrile (80:20), perform linear gradient elution according to Table 2:

[0077] Table 2 Gradient elution program

[0078]

[0079]

[0080] Experimental procedure: 0.05mol / L ammonium acetate aqueous solution (adjust pH value to 5.70 with glacial acetic acid) as mobile phase A, use 0.05mol / L ammonium acetate aqueous solution (adjust pH value to 5.70 with glacial acetic acid)-acetonitrile (80:20) It is mobile phase B, eluted according to the gradient in Table 2, the flow rate is 0.8ml / min, the detection wavelength is 214nm, and the column temperature is 30°C; take amoxicillin an...

Embodiment 3

[0083] Experimental equipment and conditions:

[0084] Agilent high performance liquid chromatography; DAD detector; Waters Atlantis T3, 5μm, 250×4.6mm as the separation column.

[0085] Detection conditions:

[0086] Flow rate: 1.2ml / min; Detection wavelength: 214nm; Column temperature: 30°C; 0.05mol / L ammonium acetate aqueous solution (adjust the pH value to 5.70 with glacial acetic acid)-acetonitrile (80:20), perform linear gradient elution according to Table 3:

[0087] Table 3 Gradient elution program

[0088]

[0089] Experimental procedure: 0.05mol / L ammonium acetate aqueous solution (adjust pH value to 5.70 with glacial acetic acid) as mobile phase A, use 0.05mol / L ammonium acetate aqueous solution (adjust pH value to 5.70 with glacial acetic acid)-acetonitrile (80:20) It is mobile phase B, eluted according to the gradient in Table 3, the flow rate is 1.2ml / min, the detection wavelength is 214nm, and the column temperature is 30°C; take amoxicillin and clavulanat...

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Abstract

The invention discloses a liquid chromatography method for determining clavulanic acid related substances in an amoxicillin and clavulanic acid potassium pharmaceutical composition. According to the method, octadecylsilane chemically bonded silica is used as a filler, an ammonium acetate aqueous solution is used as a mobile phase A, an ammonium acetate aqueous solution-acetonitrile is used as a mobile phase B, linear gradient elution is carried out, and the pH value of the ammonium acetate aqueous solution is 5.60-5.80. The method provided by the invention can be used for effectively detectingthe clavulanic acid impurities in the amoxicillin and clavulanic acid potassium pharmaceutical composition, is high in separation degree, simple and feasible, low in analysis cost, accurate and reliable in result, and convenient for controlling the product quality in the production and quality control process.

Description

technical field [0001] The invention belongs to the field of drug impurity analysis and detection, and in particular relates to a liquid chromatography method for determining related substances of clavulanic acid in amoxicillin-clavulanate potassium pharmaceutical composition. Background technique [0002] Amoxicillin is one of the most commonly used broad-spectrum β-lactam antibiotics. It has strong bactericidal effect and ability to penetrate cell membranes, but it is unstable to β-lactamase. Clavulanic acid is an irreversible competitive β-lactamase inhibitor. The combination of the two can protect amoxicillin from β-lactamase hydrolysis and significantly enhance the antibacterial effect of amoxicillin. Clinically, it is widely used in the treatment of various infectious diseases. [0003] The chemical structural formula of Clavulanate Potassium is: [0004] [0005] It is known in the art that the chemical properties of potassium clavulanate are unstable, and it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 江玉婷李雯杨文玲薛其俊吴暎李薇任晋生
Owner JIANGSU SIMCERE PHARMA
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