High Performance Liquid Chromatography Prulifloxacin tablets and related substances.docVIP

 PAGE \* MERGEFORMAT 15 High Performance Liquid Chromatography Prulifloxacin tablets and related substances Authors: WANG Qi, LI Zhi-feng, Xu Yan, Yue-Hu Pei 【Abstract】 Objective To establish high-performance liquid chromatography chip Prulifloxacin examination of related substances and determination. Methods Diamonsil-C18 column (4.6mm × 200mm, 5μm), in order to 0.01mol / L triethylamine aqueous solution (pH adjusted to 2.8 with phosphoric acid) - acetonitrile (73:27) as mobile phase; detection wavelength 278nm; flow rate 1.0ml/min; column temperature 30 ℃; injection volume 10μl. Results preparations auxiliary interference-free determination of the main drug, Prulifloxacin related substances completely separate. The 10.0 ~ 200.0μg/ml within the peak area and concentration showed good linearity. Precision (RSD = 0.13%) good. The average recovery was 99.6%. Conclusion The method is simple, rapid, accurate, specific and strong. Keywords: Prulifloxacin; tablets; high-performance liquid chromatography; determination; related substances Determination of prulifloxacin and its related substances in tablets by HPLC 【Abstract】 Objective To establish an HPLC-UV method for the determination of prulifloxacin and its related substances in tablets. Methods Diamonsil-C18 column (4.6mm × 200mm, 5μm) was used. The mobile phase is consisted of 0.01mol / L triethylamine (pH was adjusted to 2.8 using phosphoric acid)-acetonitrile (73:27). The flow rate was 1.0 ml / min with UV detection at 278nm. The column temperature was 30 ℃. The injection volume was 10μl.Results The linear range for the content of prulifloxacin was 10.0 ~ 200.0μg/ml (r = 0.9999 3, n = 5). The recoveries of prulifloxacin tablets were 99.6%, and its RSDs were 0.14%. Conclusion The method is sample, efficient, accurate and specific. 【Keywords:】 prulifoxacin; tablets; HPLC; content determination; related substances Prulifloxacin is a new broad-spectrum fluo