{"title":"Stability Indicating Assay Method and LC-MS Characterization of Forced Degradation Products of Pantoprazole and Aspirin.","authors":"Tinkal S Patel, Ankit B Chaudhary","doi":"10.1093/chromsci/bmaf029","DOIUrl":null,"url":null,"abstract":"<p><p>To assess the degradation of the drug under forced degradation, stability experiments with aspirin and pantoprazole were performed. Under the guidelines set forth by the International Conference on Harmonization, pantoprazole and aspirin were exposed to oxidation, alkaline and acidic hydrolysis and thermal stress. Under basic and acidic hydrolysis stress, the drug combination demonstrated significant degradation. Under conditions of oxidative stress and heat, however, it remained stable. A mobile phase, containing methanol: ammonium acetate buffer (0.01 M) (70: 30% v/v) was employed, a column (250 mm × 4.6 mm, and 5 μm), detection wavelength was 254 nm, flow rate of 0.8 mL min-1 was used. The degradation products were identified using LC-MS, and fragmentation paths were suggested. (Graphical abstract: Figure 1).</p>","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 5","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of chromatographic science","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1093/chromsci/bmaf029","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
To assess the degradation of the drug under forced degradation, stability experiments with aspirin and pantoprazole were performed. Under the guidelines set forth by the International Conference on Harmonization, pantoprazole and aspirin were exposed to oxidation, alkaline and acidic hydrolysis and thermal stress. Under basic and acidic hydrolysis stress, the drug combination demonstrated significant degradation. Under conditions of oxidative stress and heat, however, it remained stable. A mobile phase, containing methanol: ammonium acetate buffer (0.01 M) (70: 30% v/v) was employed, a column (250 mm × 4.6 mm, and 5 μm), detection wavelength was 254 nm, flow rate of 0.8 mL min-1 was used. The degradation products were identified using LC-MS, and fragmentation paths were suggested. (Graphical abstract: Figure 1).
为了评价该药物在强制降解条件下的降解情况，分别与阿司匹林和泮托拉唑进行了稳定性实验。根据国际协调会议制定的指导方针，泮托拉唑和阿司匹林暴露于氧化、碱性和酸性水解以及热应力下。在碱性和酸性水解胁迫下，药物组合表现出明显的降解。然而，在氧化应激和高温条件下，它保持稳定。流动相为甲醇：醋酸铵缓冲液（0.01 M） （70: 30% v/v），色谱柱（250 mm × 4.6 mm, 5 μm），检测波长254 nm，流速0.8 mL min-1。采用LC-MS对降解产物进行了鉴定，并提出了裂解路径。（图形摘要：图1）。
期刊介绍：
The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
