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High performance liquid chromatography method for measuring doripenem content

A high-performance liquid chromatography, content technology, applied in the field of drug analysis, can solve problems such as inconvenience, harsh buffer requirements, and low sensitivity

Inactive Publication Date: 2008-06-04
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the shortcomings of the content determination method of doripenem in the prior art, such as harsh requirements on buffer pH, low sensitivity and inconvenient

Method used

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  • High performance liquid chromatography method for measuring doripenem content
  • High performance liquid chromatography method for measuring doripenem content
  • High performance liquid chromatography method for measuring doripenem content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Get octylsilane bonded silica gel chromatographic column; Mobile phase is the NaH of 0.2mol / L 2 PO 4 Aqueous solution (adjusted to pH 5.0 with NaOH):acetonitrile=100:4; detection wavelength is 292nm.

[0063] Accurately weigh 25.7 mg of doripenem raw material (purchased from Shionogi Company, Japan), put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; accurately weigh 25.4 mg of doripenem standard product. mg, put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as a standard solution. Inject 10 μL respectively, record the chromatogram, and measure the peak area of ​​doripenem. The calculated doripenem content was 99.13%.

Embodiment 2

[0065] Get octylsilane bonded silica gel chromatographic column; Mobile phase is the Na of 0.01mol / L 2 HPO 4 Aqueous solution (adjusted to pH 5.3 with NaOH):acetonitrile=100:7; detection wavelength is 292nm.

[0066] Accurately weigh 24.3 mg of doripenem raw material (purchased from Japan Shionogi Company), put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; accurately weigh 25.6 mg of doripenem standard product. mg, put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as a standard solution. Inject 10 μL respectively, record the chromatogram, and measure the peak area of ​​doripenem. The calculated doripenem content was 99.31%.

Embodiment 3

[0068] Get octylsilane bonded silica gel chromatographic column; Mobile phase is the Na of 0.1mol / L 3 PO 4 Aqueous solution (adjusted to pH 6.0 with phosphoric acid):acetonitrile=100:2; detection wavelength is 292nm.

[0069] Accurately weigh 25.5 mg of doripenem raw material (purchased from Japan Shionogi Company), put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; accurately weigh 25.0 mg of doripenem standard product. mg, put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as a standard solution. Inject 10 μL respectively, record the chromatogram, and measure the peak area of ​​doripenem. The calculated doripenem content was 98.91%.

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Abstract

The invention discloses a method of detecting the content of doripenem with high performance liquid chromatography, which adopts an ultraviolet detector for detecting. The invention is characterized in that: the method adopts an octyl chemically bonded silica chromatographic column as the chromatographic column, and acetonitrile and solium salt aqueous solution of phosphoric acid as the mobile phase, and the pH of the solium salt aqueous solution of phosphoric acid is 5.0-6.0. The invention has simple operation, high sensitivity and good peak form, and can detect the doripenem in the range of pH 5.0-6.0.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for determining the content of doripenem by high performance liquid chromatography. Background technique [0002] With the extensive use of antibiotics in clinical practice, the phenomenon of bacterial drug resistance is becoming more and more serious. In the research and development of new antibiotics, in recent years, foreign countries are shifting from the research field of typical β-lactam antibiotics to the research field of atypical β-lactam antibiotics. Carbapenem antibiotics are a type of atypical β-lactam antibiotics. [0003] Doripenem (doripenem) is a new broad-spectrum carbapenem antibiotic developed by Shionogi Corporation of Japan. It has the characteristics of broad antibacterial spectrum and stability to most β-lactamases. This product was launched in Japan in September 2005, and has good clinical application value and market prospect. [0004] The content...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/28G01N33/15
Inventor 李懿睿张敏如张庆文潘红娟周一萌刘莉
Owner SHANGHAI INST OF PHARMA IND CO LTD
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