HPLC测定维生素B_(12)注射液的含量和有关物质  

Determination of Content and Related Substances in Vitamine B_(12) Injection by HPLC Method

作　　者：刘毅[1] 岳志华[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药学杂志》2010年第4期304-306,共3页Chinese Pharmaceutical Journal

摘　　要：目的建立测定维生素B12的含量和有关物质的高效液相色谱法。方法采用以十八烷基硅烷化学键合硅胶为填充剂的色谱柱，流动相为甲醇一磷酸盐缓冲液pH3．5（26：74），检测波长为361nm。结果线性浓度范围20．22～505．60mg·L^-1（r=0．99997），最低检测限为3ng，样品溶液（避光保存）至少在24h内稳定，平均回收率为100．8％，精密度（RSD=0．1％）、重复性（RSD=0．1％）良好。结论用同一高效液相色谱法来测定含量和有关物质，经方法学验证，此方法简便、灵敏、准确。OBJECTIVE To establish a high performance liquid chromatography assay for the determination of vitamine B12injection. METHODS C18 was packed in the analytical column. The mobile phase consisted of methanol-phosphate buffer solvent pH 3. 5 （26： 74）. The detection wavelength was 361 rim. RESULTS The calibration curve was linear in the range of 20. 22 to 505.60 mg · L^- 1 （ r = 0. 999 97）. The LOD was 3 ng. The sample solution kept in dark place was stable within 24 h. The average recoveries were 100. 8%. Validation（RSD = 0. 1% ） and repeatability （RSD =0. 1% ） were good. CONCLUSION This method was simple, sensitive and could be used for the quality evaluation of vitamine B12 injection.

关 键 词：维生素B12注射液 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]