HPLC法检查普卢利沙星有关物质  

The Test of Related Impurities in Prulifloxacin by HPLC

作　　者：初虹[1] 

机构地区：[1]苏州东瑞制药有限公司,江苏苏州215128

出　　处：《药学进展》2004年第9期424-427,共4页Progress in Pharmaceutical Sciences

摘　　要：目的 :建立普卢利沙星有关物质检查的HPLC法。方法 :使用C1 8柱 (2 5 0mm× 4 6mm ,5 μm) ,以 0 0 5mol L枸橼酸溶液 (用三乙胺调节pH值 3 0 ) 乙腈 (6 0∶4 0 )为流动相 ,检测波长为 2 72nm ,流速 1 0ml min。结果 :主要降解产物NM394含量在 0 4 9μg ml～ 16 4 μg ml、中间体Ⅸ在 0 2 0 μg ml～ 2 0 0 μg ml、中间体Ⅹ在 0 19μg ml～19 0 μg ml范围内峰面积与浓度的线性关系较好 ,相关系数分别为 0 99998、 0 99999、 0 99999;检测限分别为5 2ng ml、5 9ng ml、6 4ng ml。结论 :本法的准确度、精密度、专属性及耐用性好 ,可用于对普卢利沙星的有关物质检查。Objective: To establish a method for the test of impurities in prulifloxacin by HPLC. Methods: With C 18 column (250 mm×4.6 mm, 5 μm); mobile phase is 0.05 mol/L citric acid monohydrate solution, adjusting its pH 3.0 with triethylamine-acetonitrile (60∶40); detection wavelength is 272 nm and flow rate is 1.0 ml/min. Results: A main degradation, NM394 has good linear relation between concentration, 0.49 μg/ml and 16.4 μg/ml ( r =0.99998) with absorbance, which is same as Intermediate Ⅸ, 0.20 μg/ml and 20.0 μg/ml ( r =0.99999), IntermediateⅩ is 0.19 μg/ml and 19.0 μg/ml ( r =0.99999); LOD of NM394 is 5.2 ng/ml, Intermediate Ⅸ is 5.9 ng/ml, and Intermediate Ⅹ is 6.4 ng/ml. Conclusion: Veracity, pre- cision, robust and durability of the method is good, and it is suitable for detecting related impurities in pruli- floxacin.

关 键 词：普卢利沙星 检查 高效液相色谱法 HPLC法 抗菌药 

分 类 号：R927[医药卫生—药学]