HPLC法测定氟胞嘧啶及其注射液中氟尿嘧啶有关物质  

HPLC determination fluorouracil of related substance in flucytosine and flucytosine injection

作　　者：解斐[1] 凌霄 吴敬德[3] 

机构地区：[1]山东大学威海分校海洋学院,威海264209 [2]山东省药品检验所,济南250101 [3]山东大学药学院,济南250012

出　　处：《药物分析杂志》2010年第2期317-319,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:用高效液相色谱法测定氟胞嘧啶及氟胞嘧啶注射液有关物质。方法:用十八烷基硅烷键合硅胶为填充剂,以甲醇-水(用0.05mol.L-1磷酸溶液调节pH至3.5)(5:95)为流动相;流速为1.0mL.min-1;检测波长为265nm。结果:氟胞嘧啶浓度在1.2855～12.855μg.mL-1范围内与峰面积线性关系良好,r=0.9998,氟尿嘧啶在0.26～2.56μg.mL-1浓度范围内与峰面积线性关系良好,r=0.9999,氟胞嘧啶检出限0.98ng,氟尿嘧啶检出限0.59ng。结论:该方法简便、准确,较TLC法更适于该品种的质量控制。Objective：To establish HPLC method for determination of the related substances in flucytosine and flucytosine injection.Methods：The determination was carried out with a C18（4.6 mm×250 mm,5 μm）column,using methanol-water（adjust pH to 3.5 with 0.05 mol/L-1 phosphoric acid）（5∶95） as mobile phase,at a flow rate of 1.0 mL/min-1 and detected at the wavelength 265 nm.Results：The linear ranges of fluorouracil was 0.26-2.56 μg/mL-1（r=0.9996）,and the detection limit was 0.1 ng.Conclusion：This method is simple,convenient.Compared with TLC,this method is can be applied for flucytosine injections quality control better.

关 键 词：氟胞嘧啶注射液 高效液相色谱法 氟尿嘧啶 有关物质 

分 类 号：R917[医药卫生—药物分析学]