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Furbenicillin sodium and its formulation content high-performance liquid chromatogram determination method

A technology of high-performance liquid chromatography and furbucillin sodium, which is applied in the field of high-performance liquid chromatography determination of furubusillin sodium and its preparations, can solve the problems of high-performance liquid chromatography, and achieve strong practicality and Operability and the effect of reducing the inspection workload

Inactive Publication Date: 2011-06-15
张菁
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the raw materials and their preparations are included in the first volume of the Ministry of Health's drug standard antibiotic drugs, the 1989 edition, and the standard number is WS1-C2-0021-89. Chromatographic content determination and related substance inspection methods have not yet been reported to apply for administrative protection

Method used

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  • Furbenicillin sodium and its formulation content high-performance liquid chromatogram determination method
  • Furbenicillin sodium and its formulation content high-performance liquid chromatogram determination method
  • Furbenicillin sodium and its formulation content high-performance liquid chromatogram determination method

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Embodiment 1

[0015] A high performance liquid chromatography method for determining the content of furubicin sodium and its preparations. Its chemical formula is

[0016]

[0017] The test method is as follows:

[0018] (1) Using high performance liquid chromatography, chromatographic conditions: using octadecylsilane bonded silica gel as filler; mobile phase phosphate buffer: methanol 50:50, phosphate buffer using phosphoric acid to adjust the pH to 3.5 0.1mol / L potassium dihydrogen phosphate solution; flow rate 0.9ml per minute; detection wavelength 220nm; column temperature: 10℃ room temperature;

[0019] (2) Preparation of the reference substance solution of furubicin: accurately take 25mg of the reference substance of furubicin and place it in a 50ml volumetric flask, dissolve it with water and dilute to the mark;

[0020] (3) Preparation of test solution: accurately weigh 25 mg of furubicin in a 50 ml volumetric flask, dissolve it with water and dilute to the mark;

[0021] (4) Take 10μl each...

Embodiment 2

[0023] The difference from the first embodiment is that the flow rate in the first chromatographic condition is 1.2 ml per minute; the detection wavelength is 223 nm; the column temperature is 20°C and room temperature.

Embodiment 3

[0025] The difference from the first embodiment is that the flow rate in the first chromatographic condition is 1.5 ml per minute; the detection wavelength is 225 nm; the column temperature is 30°C and room temperature.

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Abstract

The utility model discloses a high performance liquid chromatography method for fubuxilin sodium and the preparation content, comprising following steps: firstly, control substance solution and test solution are prepared, then 10 Mu L of the test solution and the control substance solution are injected into a color spectrometer, the chromatography is recorded, and the content of the obtained fubuxilin sodium and the injection of fubuxilin sodium with the peak area is calculated according to the external standard method. The method can not only effectively and accurately test the content of the fubuxilin sodium and the preparation content, and can greatly reduce the testing workload of the relevant enterprises and supervision testing departments; therefore, the method is very practicable and workable in the production of the drug and the preparation and the control of quality.

Description

Technical field [0001] The invention relates to a method for determining the content of antibiotic drugs, in particular to a high-performance liquid chromatography method for determining the content of furubicillin sodium and its preparations. Background technique [0002] Furubicillin sodium is a ureido derivative of aminopenicillin. It is a broad-spectrum semi-synthetic penicillin. It has strong antibacterial activity against Haemophilus influenzae, Proteus mirabilis, S. typhi, part of Escherichia coli and Pseudomonas aeruginosa. Gram-negative bacteria such as spores have good antibacterial effects and are mainly used clinically for infections caused by Pseudomonas aeruginosa. At present, the raw materials and their preparations are included in the 1989 edition of the first volume of drug standards for antibiotics of the Ministry of Health. The standard number is WS1-C2-0021-89. The content determination method is residual acid-base titration, but high-performance liquid There...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 张菁王金龙姜建国
Owner 张菁