摘要
Abstract
Objective To adopt the RP - HPLC method to determine the NM394 content and related substances in Prulifloxacin Tablets. Methods The separation was performed on The Phenomenex C18 column(150 mm × 4. 6 mm,5 μm). The mobile phase A was 0. 025 mol / L sodium phosphate monobasic dihydrate solution(adjusting to pH = 6. 0 with triethylamine);the mobile phase B was ace-tonitrile. The flow rate was 1. 0 mL / min with the gradient elution. The detection wavelength was 276 nm. Results The mass concentra-tion of NM394 in the range of 1. 2 - 28. 8 μg / mL exhibited good linear relation with the peak area( r = 0. 999 1,n = 6). The average recovery rates in the high,middle and low mass concentrations were 98. 8% ,99. 7% and 99. 4%( n = 3) respectively,with RSD of 0. 99% ,0. 61% and 0. 43% ( n = 3 ) respectively. Conclusion The method is proved to be quick,simple and accurate and is suitable for the determination of the NM394 content and its related substances in Prulifloxacin Tablets.关键词
普卢利沙星/NM394/有关物质/反相高效液相色谱法Key words
prulifloxacin/NM394/related substance/RP - HPLC分类
医药卫生
