Avibactam sodium substance analysis method

Abstract

The invention discloses an avibactam sodium analysis method, relates to the field of medicine detection, and aims to provide an avibactam sodium related substance analysis method with high sensitivity and good stability. The chromatographic conditions are that a hydrophilic C18 column is adopted as a chromatographic column; the mobile phase A is a 10 mmol / L-50 mmol / L monopotassium phosphate solution, the mobile phase B is 10 mmol / L-50 mmol / L monopotassium phosphate-acetonitrile (80: 20-30: 70), and gradient elution is carried out; the column temperature is 25-40 DEG C; the flow velocity is 0.5 mL / min to 1.2 mL / min; the sample size is 20 mu L; and the sample concentration is 1 mg / mL to 10 mg / mL. The method has the advantages of high detection sensitivity, good reproducibility, high stability and the like, and is suitable for detecting the avibactam sodium related substances.

Description

technical field [0001] The invention relates to the field of medical detection, in particular to an analysis method for avibactam sodium substances. Background technique [0002] Avibactam sodium is a β-lactamase inhibitor. So far, the most successful antibacterial drug synergists are β-lactamase inhibitors. β-lactam drugs have good characteristics of high efficiency and low toxicity, and are widely used in antibacterial treatment, but with the use of β-lactam drugs, bacteria produce β-lactamase and change the cell wall or outer membrane Mechanisms such as permeability, target protein mutation, and expression of efflux pumps are resistant to such drugs, and the most important mechanism is to produce β-lactamase to cause drug hydrolysis and inactivation. Therefore, selection and β-endogenous Combination of amidase inhibitors can enhance the sensitivity of the drug. [0003] Classical β-lactamase inhibitors belong to β-lactam compounds, which form a covalent bond Michaelis ...

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Problems solved by technology

[0004] The detection of related substances is an important testing item for quality control in the process of drug development. At present, no relevant reports have been found on the detection methods of related substances of avibactam sodium. Due to its structural characteristics, the main difficulty in its separation is that its retention time is too short , the retention time of conventional chromatographic conditions is within 5 minutes, it is difficult to separate it from other impurities, and when encountering different proportions of organic solvents as mobile phases, the main peak will become a double peak phenomenon, so a kind of The method for detecting related substances of avibactam is of great significance in the process of drug quality control

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