HPLC法测定谷氨酸诺氟沙星注射液的有关物质及含量  

Determination of norfloxacin glutamate injection by HPLC

作　　者：李萌[1] 王剑 丁维剑[1] 

机构地区：[1]安徽省巢湖市第一人民医院,安徽巢湖238000 [2]安徽安中科兴医药科技有限公司,安徽合肥230038

出　　处：《安徽医药》2007年第6期514-516,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的采用HPLC法测定谷氨酸诺氟沙星注射液的有关物质及含量。方法采用ODS柱,以0.025 mol.L-1磷酸溶液(用三乙胺调节pH值至3.0)-乙腈(84∶16)为流动相,检测波长为278 nm。谷氨酸诺氟沙星在18.8～93.9 mg.L-1范围内线性关系良好(r=0.999 8),检测限为0.298 ng,平均回收率为99.80%,RSD为0.59%。结果在本文所设计的实验条件下,有关物质检查的专属性较好。在含量测定条件下,该方法的线性范围、回收率、精密度、重复性、耐用性及稳定性的考察结果都较满意。结论采用HPLC法对谷氨酸诺氟沙星注射液的有关物质和含量进行测定具有专属性强,结果准确及操作简便等优点。Aim To determine the contents of related substances in norfloxacin glutamate injection by HPLC. Methods An ODS column was used with the mobile phase of 0. 025 mol·L phosphoric acid （pH 3.0 ,adjusted with triethylamine）-acetonitrile（ 84：16 ）, at the detection wavelength of 278 nm. The calibration curve was linear in the range form 18.8 to 93.9 mg· L^- 1 （ r = 0.9998 ）. The detection limit was 0. 298 ng. The average recovery was 99.80% ,with RSD of 0.59%. Results By using this method, the specificity of the determina- tion is relatively good. The outcomes of linear range, recovery range, precision, reproducibility, durability and stability are also satisfactory. Conclusion This method is specific,precise and simple.

关 键 词：谷氨酸诺氟沙星 高效液相色谱法 有关物质 含量测定 

分 类 号：R927.2[医药卫生—药学]