石家庄学院学报

以乙腈-甲醇-0.05 mol/L磷酸二氢钾溶液(10∶20∶70)(用磷酸调节pH值为4.0)为流动相,采用迪马钻石C18(250 mm×4.6 mm,5μm)色谱柱及紫外检测器,建立了甲钴胺注射液中甲钴胺含量的反相高效液相色谱检测方法.柱温:40℃;检测波长为264 nm;流速:1.0 mL/min.本方法测定的日内精密度为0.59%,日间精密度为0.67%,回收率为99.7%～100.5%,在160～240μg/mL范围内线性关系满足要求(r=0.999 9);结果表明方法准确、操作简单、专属性强,可用于定量测定甲钴胺注射液含量.

A reversed phase high performance liquid chromatography method was established to determine Mecobalamin in Mecobalamin injection.Mecobalamin was determined by HPLC with UV detector,Diamonsil C18(250 mm ×4.6 mm,5μm)and acetonitrile-methanol-50mmoL/L Potassium dihydrogen phosphate buffer solution(10:20:70)(adjusted pH to 4.0 by Phosphate)as mobile phase,the detection wave length was 264 nm,the oven temperature was 40℃,the flow rate was 1.0mL·min-1.The determination results of HPLC showed that within-day precision was 0.59%,day to day precision was 0.67% and recoveries of Mecobalamin were within 99.7%～100.5%,the linear range was 160～240mg/ml for Mecobalamin(r=0.9999).The method is accurate,simple,rapid and exclusive.Conclusion can be used for determination of Mecobalami in Mecobalamin Injection.