中国药业2013，Vol.22Issue(15)：48-50,3.
奥沙利铂静脉输液的有关物质检查与含量测定
Determination of Content and Related Substances of Oxaliplatin Intravenous Infusion
徐静 1张伟明 2李健和 3易利丹 3彭六保3
作者信息
- 1. 湖南省交通医院药剂科,湖南长沙410005
- 2. 湖南省妇幼保健院药剂科,湖南长沙410008
- 3. 中南大学湘雅二医院药学部,湖南长沙 410011
- 折叠
摘要
Abstract
Objective To establish a HPLC method to determine the oxaliplatin content and the related substances of oxaliplatin intravenous infusion.Methods The HPLC method was adopted to determine the oxaliplatin content and related substances in oxaliplatin intravenous infusion.The Polaris C18-A column (200 mm×4.6 mm; 5 μm) was adopted with methanol-water(10 ∶ 90) as the mobile phase at the flow rate of 0.8 mL/min.The detection wavelength was set at 249 nm.The theoretical plate number was not less than 2 000 according to the peak of oxaliplatin.At the same time,the classic oxidimetry method for the determination of isotonic regulator mannite was established,which using the back titration with sodium thiosulfate titrant.Results The linear relation of oxaliplatin was excellent within the concentration range of 0.10-1.00 g/L(r=0.999 8),the limit of the detection was 0.06 μg.The average recovery rates of oxaliplatin and mannitol were 100.17％ (RSD =0.53％) and 100.54％ (RSD =0.34％),respectively.Conclusion This method is specific,accurate,sensitive and rapid with the reliable detection Results.关键词
奥沙利铂静脉输液/高效液相色谱法/氧化还原滴定法/有关物质/含量测定Key words
oxaliplatin intravenous infusion/HPLC/oxidimetry/related substances/content determination分类
医药卫生引用本文复制引用
徐静,张伟明,李健和,易利丹,彭六保..奥沙利铂静脉输液的有关物质检查与含量测定[J].中国药业,2013,22(15):48-50,3.
