A method for detecting related substances of piperacillin sodium and sulbactam sodium for injection

A technology of cillin sodium sulbactam sodium and related substances, which is applied in the field of detection of related substances of piperacillin sodium sulbactam sodium for injection, and can solve problems such as long detection time

Active Publication Date: 2018-08-07
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In order to overcome the problem that the detection time that existing related substance detection method exists is too long, the invention provides a kind of method for rapid detection piperacillin sodium sulbactam sodium related substance:

Method used

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  • A method for detecting related substances of piperacillin sodium and sulbactam sodium for injection
  • A method for detecting related substances of piperacillin sodium and sulbactam sodium for injection
  • A method for detecting related substances of piperacillin sodium and sulbactam sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: Detection of related substances of piperacillin sodium and sulbactam sodium for injection

[0027] 1. Solution configuration

[0028] Test solution: piperacillin sodium sulbactam sodium powder for injection (manufacturer: Suzhou Erye Pharmaceutical Co., Ltd., specification 2:1) was dissolved in mobile phase A and diluted to a solution with a concentration of 2.5 mg / ml. Shake well, as the test solution;

[0029] Reference substance solution: Accurately measure 1ml of the test solution, put it in a 100ml measuring bottle, dilute to the mark with mobile phase A, shake well, and use it as a reference solution;

[0030] Mobile phase A: tetrabutylammonium hydroxide solution [water: 3.12% sodium dihydrogen phosphate solution: 20% tetrabutylammonium hydroxide solution (576:200:9.6)]-acetonitrile (786:200), adjust the pH to 6.0 with phosphoric acid mobile phase A;

[0031] Mobile phase B: tetrabutylammonium hydroxide solution [water: 3.12% sodium dihydrogen phos...

Embodiment 2

[0042] Example 2: System suitability test of piperacillin sodium and sulbactam sodium for injection

[0043] Using the same detection conditions as in Example 1, the column temperature, flow rate and pH of the mobile phase were investigated respectively, and the results are shown in Table 1.

[0044] Table 1. System suitability test of piperacillin sodium and sulbactam sodium for injection

[0045]

[0046] Note: Piperacillin impurity E is the first peak, and its resolution is not shown on the spectrum. The separation of piperacillin impurity E and sulbactam impurity A is the resolution under sulbactam impurity A, followed by By analogy, the degree of separation under the item of piperacillin impurity E is represented by “——”.

[0047] The above test results show that when the column temperature and flow rate have slight changes, the resolution of the system applicability test of this method is better. However, when the pH value of the mobile phase changes, the number of ...

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Abstract

The invention provides a method for detecting relevant substances in piperacillin sodium and sulbactam sodium for injection. According to the method, octadecylsilane bonded silica gel is adopted as filler and tetrabutyl ammonium hydroxide solution-acetonitrile is adopted as a moving phase for gradient elution, and measurement of the relevant substances in piperacillin sodium and sulbactam sodium is realized quickly and accurately.

Description

technical field [0001] The invention relates to a method for detecting related substances of piperacillin sodium and sulbactam sodium for injection. Background technique [0002] Piperacillin sodium is a semi-synthetic penicillin, which inhibits the synthesis of bacterial cell walls by binding to bacterial penicillin-binding proteins (PBPs) to play a bactericidal effect. It has the characteristics of broad-spectrum and low toxicity, but it is easily hydrolyzed by β-lactamase produced by bacteria to produce drug resistance. Sulbactam sodium is a β-lactamase inhibitor, which can inhibit Ⅱ-Ⅴ type β-lactamase, and is a competitive and irreversible inhibitor. [0003] The 2010 edition of the Chinese Pharmacopoeia includes a piperacillin sodium and sulbactam sodium for injection, which is a compound preparation composed of piperacillin sodium and sulbactam sodium in a ratio of 4:1. After the combined application of piperacillin and sulbactam, the antibacterial activity of pipera...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 张健朱炜陆文娟郭顺王宁
Owner SUZHOU ERYE PHARMA CO LTD
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