title: A comparative uncertainty study of the calibration of macrolide antibiotic reference standards using quantitative nuclear magnetic resonance and mass balance methods.
abstract: This study introduces the general method of quantitative nuclear magnetic resonance (qNMR) for the calibration of reference standards of macrolide antibiotics. Several qNMR experimental conditions were optimized including delay, which is an important parameter of quantification. Three kinds of macrolide antibiotics were used to validate the accuracy of the qNMR method by comparison with the results obtained by the high performance liquid chromatography (HPLC) method. The purities of five common reference standards of macrolide antibiotics were measured by the 1H qNMR method and the mass balance method, respectively. The analysis results of the two methods were compared. The qNMR is quick and simple to use. In a new medicine research and development process, qNMR provides a new and reliable method for purity analysis of the reference standard.
authors.affiliation: National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, People's Republic of China.
authors.forename: Shu-Yu
authors.initials: SY
authors.lastname: Liu
authors.forename: Chang-Qin
authors.initials: CQ
authors.lastname: Hu
mesh_terms: D000900:Anti-Bacterial Agents / Q000737:chemistry*; D002138:Calibration; D018942:Macrolides / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy / Q000379:methods*; D015394:Molecular Structure; D012015:Reference Standards; D035501:Uncertainty
chemical_list: D000900:Anti-Bacterial Agents; D018942:Macrolides