Method for detecting related substances in piperacillin sodium
Through high-performance liquid chromatography, the problem of fewer impurities and long analysis time in the existing piperacillin sodium impurity detection methods is solved through high-performance liquid chromatography, and the rapid and accurate detection of various impurities in piperacillin sodium is achieved, improving the efficiency of quality control.
CN119715861APending Publication Date: 2025-03-28NORTH CHINA PHARM GRP SEMISYNTECH CO LTD
2 Cites 0 Cited by
Patent Information
- Application Number
- CN202411919075.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-25
- Publication Date
- 2025-03-28
AI Technical Summary
Technical Problem
The existing piperacillin sodium impurity detection methods have the problem of fewer impurities detected or too long analysis time, which is difficult to meet the needs of piperacillin sodium quality control.
Method used
High performance liquid chromatography is used to achieve rapid quantitative detection of various impurities in piperacillin sodium through specific chromatographic columns, mobile phase composition and gradient elution conditions.
Benefits of technology
This method can detect 25 impurities in piperacillin sodium, including pharmacopoeia and non-pharmacopoeia impurities, in 33 minutes, improving detection efficiency and accuracy, while reducing reagent consumption and detection costs.
✦ Generated by Eureka AI based on patent content.
Abstract
The invention provides a method for detecting related substances in piperacillin sodium. The octadecyl silane bonded silica gel chromatographic column is adopted for gradient elution, and quantitative detection of 25 impurities in piperacillin sodium is rapidly and accurately achieved by optimizing chromatographic column filler and specification, mobile phase concentration, gradient elution conditions and the like. Detection results show that all related substances are well separated from the main component piperacillin. Through methodology verification, the detection method provided by the invention has the advantages of high separation degree, accurate result and good stability, can realize detection of 25 impurities in piperacillin sodium within 33min, and can significantly improve the detection efficiency and reduce the detection cost. The 25 impurities cover related substances in the production, storage and stability test processes of piperacillin sodium. The detection method can be used as a stability indication method of piperacillin sodium, is used for quality control of piperacillin sodium, and has a wide application prospect.
Need to check novelty before this filing date? Find Prior Art