高效液相色谱法同时测定多索茶碱注射液中9种杂质的含量  

Simultaneous determination of 9 impurities in doxofylline injection by HPLC

作　　者：李锋武 范菲 周娜 冯琴琴 LI Feng-wu;FAN Fei;ZHOU Na;FENG Qin-qin(Xi’an Institute for Food and Drug Inspection,Xi’an 710061;The 521st Hospital of Ordnance Industry,Xi’an 710065)

机构地区：[1]西安市食品药品检验所,西安710061 [2]兵器工业五二一医院,西安710065

出　　处：《中南药学》2024年第8期2197-2200,共4页Central South Pharmacy

基　　金：国家药品抽检项目(No.国药监药管[2023]2号)。

摘　　要：目的建立高效液相色谱法同时测定多索茶碱注射液中9种杂质的含量。方法使用CAPCELL PAK C18 ME色谱柱(4.6 mm×250 mm,5μm);以乙腈-磷酸盐缓冲液为流动相,梯度洗脱,流速为1.0 mL·min^(-1),柱温为30℃,检测波长为273 nm。对多索茶碱注射液中可能存在的9种杂质进行定量分析和限度检查。结果在该条件下,9种杂质均能完全分离,回收率均在97.0%~105.0%。结论该方法专属性强,重复性好,可用于多索茶碱注射液有关物质的测定。Objective To determine 9 impurities in doxofylline injection by high performance liquid chromatography(HPLC).Methods A CAPCELL PAK C18 ME column(4.6 mm×250 mm,5μm)was used.Acetonitrile-phosphate buffered saline was used as the mobile phase,with gradient elution.The flow rate was 1.0 mL·min^(-1),the column temperature was 30℃,and the detection wavelength was 273 nm.Nine possible impurities in doxofylline injection were quantitatized and the limit was checked.Results Under these conditions,the 9 impurities were completely separated,with recoveries between 97.0%~105.0%.Conclusion This method is specific and reproducible,and can be used for the determination of related substances in doxofylline injection.

关 键 词：多索茶碱注射液 高效液相色谱法 杂质 

分 类 号：R927[医药卫生—药学]