LC-ESI-MS Determination of Roxithromycin in Tissues of Beagle Dogs after Multiple Dosing of Roxithromycin Sustained Release Tablets

• Published in: Chromatographia Vol. 66; no. 7-8; pp. 475 - 480
• Main Authors: Zha, Weibin, Sun, Jianguo, Wang, Guangji, Ren, Hongcan, Hu, Xiaoling, Huang, Qing, A, Jiye
• Format: Journal Article
• Language: English
• Published: Oxford Wiesbaden : Vieweg Verlag 01.10.2007; Springer
• Subjects: Analysis; Beagle dogs; Biological and medical sciences; General pharmacology; LC-ESI-MS; liquid chromatography; Medical sciences; Pharmacology. Drug treatments; roxithromycin; tissue distribution; Chemical analysis; HPLC chromatography; Roxithromycin; Solvent extraction; Electrospray; Tissue; Sample preparation; Tablet; Dog; Quantitative analysis; Validation; Fissipedia; Carnivora; Liquid liquid extraction; Controlled release form; Coupled method; Oral administration; Macrolide; Column liquid chromatography LC-ESI-MS Roxithromycin Beagle dogs Tissue distribution; Vertebrata; Antibiotic; Mammalia; Animal; Distribution; Antibacterial agent; Pharmacokinetics; Mass spectrometry
• ISSN: 0009-5893; 1612-1112
• DOI: 10.1365/s10337-007-0340-5

Roxithromycin, often regarded as an 'advanced-generation' macrolide, is widely used throughout the world. To exactly evaluate the efficacy of roxithromycin sustained release tablets on tissue pharmacokinetic and pharmacodynamic parameters, we developed a reliable LC-ESI-MS method for the determination of roxithromycin in beagle dog tissues. The overall chromatographic run time was 3.2 min. This method involved the homogenization of tissues followed by an economical liquid-liquid extraction in 2.0 mL Eppendorf tubes. Selected ion monitoring (SIM) in positive mode was used for the quantification of roxithromycin at m/z 837.45 and clarithromycin (internal standard) at m/z 748.45. The method was validated to be accurate, precise and rugged with good linearity in all tissue homogenates. The method has been successfully applied to determine roxithromycin in many dog tissues and has been used for tissue distribution of roxithromycin studies. The present study demonstrates that the highest tissue concentration of roxithromycin was observed in the liver, followed by lung, spleen, kidney and heart after multiple dosing of sustained release tablets.