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Detection method of impurities in meropenem

A technology of meropenem and a detection method, which is applied in the field of detection of impurities in meropenem, can solve the problems of poor separation of polymer impurities, inability to separate various polymer impurities, and hindering the monitoring and research of meropenem polymer impurities. , to achieve the effect of good separation

Active Publication Date: 2015-08-05
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the inventor found experimentally that the existing gel chromatography cannot separate various polymer impurities, which hinders further monitoring and research on meropenem polymer impurities
The inventor infers that the reason for the poor separation of polymer impurities may be that the meropenem polymer is mostly a dimer, and the meropenem impurity B is an isomer of the dimer. Therefore, the existing method cannot be well Effective separation of meropenem polymer from impurity B

Method used

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  • Detection method of impurities in meropenem
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  • Detection method of impurities in meropenem

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Embodiment 1

[0030] Embodiment 1 Detection method of the present invention

[0031] Mobile phase: 0.025mol / L sodium dihydrogen phosphate buffer (adjust pH=6.00 with 0.5mol / L sodium hydroxide solution); flow rate: 0.8ml / min.

[0032] Determination steps:

[0033] Weigh 13.65mg of a sample of meropenem for injection, place it in a 10ml volumetric flask, add water to dissolve it, and adjust the volume to the mark as the sample solution. Get the sample solution and carry out high performance liquid chromatography analysis according to the above conditions, the results are as follows: figure 1 , Three impurities a, b, and c were isolated from the meropenem sample, of which the total content of a and b was 0.43%.

Embodiment 2

[0034] Embodiment 2 detection method of the present invention

[0035] Mobile phase: 0.02mol / L sodium dihydrogen phosphate buffer (adjust pH=6.00 with 0.5mol / L sodium hydroxide solution); flow rate: 0.8ml / min.

[0036] Determination steps:

[0037] Weigh 13.45mg of meropenem sample for injection, place it in a 10ml volumetric flask, add water to dissolve it, and adjust the volume to the mark as the sample solution. Get the sample solution and carry out high performance liquid chromatography analysis according to the above conditions, the results are as follows: figure 2 , Three impurities a, b, and c were isolated from the meropenem sample, of which the total content of a and b was 0.55%.

Embodiment 3

[0038] Embodiment 3 detection method of the present invention

[0039] Mobile phase: 0.03mol / L sodium dihydrogen phosphate buffer solution (adjust pH=6.00 with 0.5mol / L sodium hydroxide solution); flow rate: 0.8ml / min.

[0040] Determination steps:

[0041] Weigh 13.67 mg of a meropenem sample for injection, place it in a 10 ml volumetric flask, add water to dissolve it, and adjust the volume to the mark as the sample solution. Get the sample solution and carry out high performance liquid chromatography analysis according to the above conditions, the results are as follows: image 3 , Three impurities a, b, and c were isolated from the meropenem sample, of which the total content of a and b was 0.57%.

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Abstract

The invention provides a detection method for impurities in meropenem. The detection method comprises the following operation steps of: (1) taking a meropenem sample, adding water so as to dissolve and dilute the meropenem sample into a sample solution; and (2) taking the sample solution, and injecting into a high performance liquid chromatograph to detect, wherein chromatographic conditions are as follows: a rigid spherical silica gel chemical bonding hydrophilic compound serves as a filler of a chromatographic column, a phosphate buffer with pH of 6.00+ / -0.05 serves as a mobile phase and is used for isocratic elution, and the ultraviolet detection wavelength is 220+ / -2nm. The detection method provided by the invention can be used for effectively separating the impurities in the meropenem with good degree of seperation, thus the content of different impurities can be more accurately worked out, and the possibility is provided for the further monitoring and research of the impurities in the meropenem polymer.

Description

technical field [0001] The invention relates to a method for detecting impurities in meropenem. Background technique [0002] Meropenem, a synthetic broad-spectrum carbapenem antibiotic, produces antibacterial effects by inhibiting the synthesis of bacterial cell walls. Meropenem has strong stability against the hydrolysis of most β-lactamases. Its preparation is meropenem for injection, which was launched in Italy in 1994 and in China in 1999. It is a Class B drug under national medical insurance and is used to treat inflammation such as pneumonia, gynecological infections, urinary tract infections, meningitis, skin and soft tissue infections, and sepsis. [0003] Allergic reactions sometimes occur when using this preparation, and studies have found that the allergic reactions are related to the meropenem polymer impurity in meropenem for injection. Therefore, in order to reduce the occurrence of allergic reactions, it is necessary to reduce the amount of meropenem polyme...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 姚志昂曹晓红彭捷冯冠荣卢福赵忠琼王利春沈鑫梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD