高效液相色谱法测定司帕沙星注射液的含量和有关物质  

Determination of Sparfloxacin and Related Substances in Sparfloxacin Injection by HPLC

作　　者：李红 陈光龙[2] 殷静远[2] 张彧 

机构地区：[1]广东省深圳市麒麟山疗养院药剂科,广东深圳518055 [2]广东省深圳市宝安人民医院药剂科,广东深圳518101 [3]深圳市制药厂,广东深圳518029

出　　处：《中国药业》2006年第6期14-15,共2页China Pharmaceuticals

摘　　要：目的探讨司帕沙星注射液中司帕沙星和有关物质的测定方法。方法高效液相色谱法(HPLC法);采用PhenomenexC18柱(250mm×4.6mm,5μm),以磷酸缓冲液(pH=2.5)-乙腈(65∶35)为流动相,流速为1.0mL/min,检测波长为297nm。结果司帕沙星浓度在2～50μg/mL范围内与峰面积线性关系良好,r=0.9998,平均回收率为99.80%,RSD为0.74%;有关物质的检查准确、专属性强、重现性好,最低检测限为0.5ng(S/N=3)。结论HPLC法灵敏、准确、简便,可用于该产品的质量控制。Objective To establish a method for the content determination of sparfloxacin and related substances in sparfloxacin injection. Methods HPLC was used. The determination was performed on a phenomenex C18 column（250 mm ×4.6 mm, 5 μm） with the mobile phase consisting of phosphoric buffer（pH =2. 5）-acetonitrile（65 ： 35）. The flow rate was 1.0 mL/min, the detection wavelength was at 297 nm. Results There was good linearity within the concentration range of 2-50 μg/mL（ r =0. 999 8）. The average recovery was 99. 80% （RSD = 0. 74% ）. The detection of related substances was good for accuracy, specificity and replication. The detective limit was 0. 5 ng （S/N=3）. Conclusion This method is sensitive, accurate, simple and convenient enough to be used for the quality control of sparfloxacin injection.

关 键 词：高效液相色谱法 含量测定 司帕沙星 有关物质 

分 类 号：R927.2[医药卫生—药学] R978.69