摘要
Sitafloxacin is a new fluoroquinolone antimicrobial agent with high activity. In this article, we reported a simple, rapid and specific LC-MS/MS method for accurate determination of sitafloxacin concentrations in human urine from healthy volunteers in detail. A two-step dilution method for the analysis of sitafloxacin in human urine using LC coupled to positive MS/MS has been developed and validated according to US FDA guidelines and Chinese State Food and Drug Administration (CFDA) guidelines for the validation of bioanalytical methods. The method uses 50 mu L of urine and covers a working range from 0.025 to 20 mu g/mL with a LLOQ of 0.025 mu g/mL. This new LC-MS/MS assay is sensitive and specific.
- 出版日期2014-9-15
- 单位南京医科大学