HPLC法测定盐酸左氧氟沙星氯化钠注射液中的有关物质  

Determination of Related Substances in Levofloxacin Hydrochloride and Sodium Chloride Injection by HPLC

作　　者：王胜 周玲玲 马莹莹 王娜 WANG Sheng;ZHOU Ling-ling;MA Ying-ying;WANG Na(Yantai Economic and Technological Development Area Center for Disease Control and Prevention,Yantai 264006,China;Shandong Qidu Pharmaceutical Co.,Ltd.,Zibo 255400,China)

机构地区：[1]烟台经济技术开发区疾病预防控制中心,山东烟台264006 [2]山东齐都药业有限公司,山东淄博255400

出　　处：《海峡药学》2020年第6期52-55,共4页Strait Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定盐酸左氧氟沙星氯化钠注射液的有关物质。方法采用十八烷基硅烷键合硅胶色谱柱(250×4.6mm,5μm),水为流动相,流速为1.0mL·min^-1,柱温为40℃。结果盐酸左氧氟沙星及各杂质在相应的浓度范围内,峰面积与浓度均呈良好的线性关系,相关系数均大于0.999。结论建立的方法快速、灵敏、准确,适用于盐酸左氧氟沙星氯化钠注射液中的有关物质测定。OBJECTIVE To establish a method for the determination of related substances in Levofloxacin Hydrochloride and Sodium Chloride Injection by HPLC.METHODS A Strong end-capped octadecylsilyl silica gel for chromatography(250×4.6mm,5μm)column was adopted,the mobile phase was water at a flow rate of 1.0mL·min^-1,and the column temperature was 40℃.RESULTS In the appropriate concentration range,the peak areas of levofloxacin and impurities showed a good linear relationship with the concentration respectively,and the correlation coefficients were greater than 0.999.CONCLUSION The method was rapid,sensitive,accurate,and suitable for the determination of related substances in Levofloxacin Hydrochloride and Sodium Chloride Injection.

关 键 词：左氧氟沙星 注射液 有关物质 高效液相色谱法 

分 类 号：R927[医药卫生—药学]