Identification, synthesis, isolation, and characterization of formulation related degradation impurity of Cefadroxil Oral suspension

IF 2.8 3区医学 Q2 BIOCHEMICAL RESEARCH METHODS Journal of Chromatography B Pub Date : 2025-02-28 DOI:10.1016/j.jchromb.2025.124537

Sunil Ramrao Murkute , Surenehalli Gowdra Vasantharaju , Girij P. Singh , Krishnamurthy Bhat , Himanshu M. Godbole , Pritesh R. Upadhyay , Anurag Trivedi

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Abstract

Cefadroxil is an orally active, first-generation cephalosporin antibiotic utilized in the treatment of bronchitis, pharyngitis, tonsillitis, urinary tract infections, uncomplicated skin infections, bones, and joints (de Marco and Salgado, 2017 [1]). Cefadroxil for oral suspension is formulated as dry powder for oral suspension. After reconstitution during 14 days storage, we observed an unknown impurity at relative retention time (RRT) 1.29 in cefadroxil oral suspension. The observed level of an unknown impurity was greater than 0.1 % in high-performance liquid chromatography (HPLC) analysis. The present work is focused on the identification, synthesis, and characterization of the unknown impurity by employing several sophisticated analytical techniques. Such as High-resolution mass spectroscopy (HRMS), One dimensional (1D) and two dimensional (2D) nuclear magnetic resonance spectroscopy.

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头孢地洛辛口服混悬液中处方相关降解杂质的鉴定、合成、分离和表征

Cefadroxil是一种口服活性的第一代头孢菌素抗生素，用于治疗支气管炎、咽炎、扁桃体炎、尿路感染、无并发症的皮肤感染、骨骼和关节（de Marco and Salgado, 2017[1]）。口服混悬液用头孢地呋辛配制成用于口服混悬液的干粉。在贮存14天重构后，我们在头孢地洛西口服混悬液中观察到一种相对保留时间（RRT）为1.29的未知杂质。在高效液相色谱（HPLC）分析中，观察到的未知杂质含量大于0.1%。目前的工作是集中在鉴定，合成和表征未知杂质采用几种复杂的分析技术。如高分辨率质谱（HRMS），一维（1D）和二维（2D）核磁共振波谱。

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来源期刊

Journal of Chromatography B 医学-分析化学

CiteScore

5.60

自引率

3.30%

发文量

306

审稿时长

44 days

期刊介绍： The Journal of Chromatography B publishes papers on developments in separation science relevant to biology and biomedical research including both fundamental advances and applications. Analytical techniques which may be considered include the various facets of chromatography, electrophoresis and related methods, affinity and immunoaffinity-based methodologies, hyphenated and other multi-dimensional techniques, and microanalytical approaches. The journal also considers articles reporting developments in sample preparation, detection techniques including mass spectrometry, and data handling and analysis. Developments related to preparative separations for the isolation and purification of components of biological systems may be published, including chromatographic and electrophoretic methods, affinity separations, field flow fractionation and other preparative approaches. Applications to the analysis of biological systems and samples will be considered when the analytical science contains a significant element of novelty, e.g. a new approach to the separation of a compound, novel combination of analytical techniques, or significantly improved analytical performance.