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Method for detecting cefoperazone sodium and sulbactam sodium related substances for injection

A technology for sporoperazone sodium and sulbactam sodium and a detection method is applied in the field of detection of related substances in cefoperazone sodium and sulbactam sodium for injection. The effect of high system suitability

Active Publication Date: 2020-04-24
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The 2015 edition of Chinese Pharmacopoeia contains cefoperazone, cefoperazone sodium, sulbactam and cefoperazone sodium and sulbactam sodium for injection. The impurity detection ability of the detection method is insufficient

Method used

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  • Method for detecting cefoperazone sodium and sulbactam sodium related substances for injection
  • Method for detecting cefoperazone sodium and sulbactam sodium related substances for injection
  • Method for detecting cefoperazone sodium and sulbactam sodium related substances for injection

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Embodiment 1

[0054] 1. Solution configuration

[0055] Diluent: ultrapure water and acetonitrile in a volume ratio of 1:1.

[0056] Need testing solution: take the injection cefoperazone sodium sulbactam sodium compound preparation to be tested, dissolve it with ultrapure water and make a solution containing 4mg of injection cefoperazone sodium sulbactam sodium in every 1ml, filter, and get the subsequent filtrate as need testing solution .

[0057] Reference substance solution: Take 1ml of the test solution in a 100ml measuring bottle, dilute to the mark with diluent, and shake well.

[0058] Preparation of each impurity positioning solution: take cefoperazone impurity A reference substance, cefoperazone impurity B reference substance, cefoperazone impurity C reference substance, cefoperazone impurity D reference substance, cefoperazone impurity E reference substance, cefoperazone impurity E reference substance, cefoperazone impurity Add appropriate amount of piperidone impurity F refer...

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Abstract

The invention belongs to the field of drug detection, and particularly relates to a method for detecting cefoperazone sodium and sulbactam sodium related substances for injection. The detection methodcomprises the following steps: taking a product to be detected of cefoperazone sodium and sulbactam sodium to prepare a test solution; taking 0.1% phosphoric acid solution as a mobile phase A and taking acetonitrile as a mobile phase B; and by adopting a specific gradient elution mode, effectively separating and quantitatively detecting the cefoperazone sodium and sulbactam sodium for injection and 11 related substances in a high performance liquid chromatogram. System applicability is higher, quality detection and monitoring of the cefoperazone sodium and sulbactam sodium for injection are facilitated, and safe popularization and application can be achieved.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting related substances in cefoperazone sodium and sulbactam sodium for injection. Background technique [0002] The compound preparation of cefoperazone sodium and sulbactam sodium for injection is a combination drug widely used in China recently. Cefoperazone sodium has a β-lactam structure, and sulbactam sodium is a semi-synthetic β-lactamase inhibitor, which can enhance the antibacterial effect and antibacterial spectrum when combined with cefoperazone sodium. The 2015 edition of Chinese Pharmacopoeia contains cefoperazone, cefoperazone sodium, sulbactam and cefoperazone sodium and sulbactam sodium for injection. The impurity detection ability of the detection method is insufficient. [0003] Cefoperazone sodium and sulbactam sodium for injection are prone to produce impurities when they are used as medicines. In order to control the quality of medicines more...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/54
CPCG01N30/02G01N30/06G01N30/54G01N2030/027G01N2030/062
Inventor 宋更申郑永亮李洪凯包翠香张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD