HPLC测定注射用复方三维B中盐酸呋喃硫胺、盐酸吡多胺与维生素B12的含量

目的建立HPLC测定注射用复方三维B中盐酸呋喃硫胺、盐酸吡多胺与维生素B12的含量。方法色谱柱C18柱（250 mm×4.6 mm,5μm）,流动相为庚烷磺酸钠溶液-乙腈-甲醇,采用梯度洗脱,流速为1.0 mL.min 1,检测波长为220nm,理论板数按盐酸吡多胺峰计不低于3 000,柱温为30℃。结果盐酸呋喃硫胺、盐酸吡多胺与维生素B12分别在2.04～20.4μg,2.05～20.5μg,0.020 6～0.206μg内与峰面积呈良好的线性关系（r分别为1.000,0.999 9,1.000）;平均回收率分别为101.0%,101.6%,98.3%（n=9,RSD分别为0.5%,1.4%,0.3%）。结论本法简便、准确、重复性好,适用于注射用复方三维B中盐酸呋喃硫胺、盐酸吡多胺与维生素B12的含量测定。

Determination of Fursultiamine Hydrochloride, Pyridoxamine Dihydrochloride and Vitamin B12 in Compound Trivitamin B Injection by HPLC

OBJECTIVE To establish a method to determine the content of fursultiamine hydrochloride,pyridoxamine dihydrochloride and vitamin B12 in compound trivitamin B injection.METHODS C18 column(250 mm×4.6 mm,5 μm) was adopted,the mobile phase was a mixture of sodium heptanesulfonate solution-acetonitrile-methanol,and elute with linear gradient.The flow rate was 1.0 mL·min-1 and detection wavelength was 220 nm.The theoretical plate number calculated by the peak of pyridoxamine dihydrochloride was not less than 3 000 and column temperature was 30 ℃.RESULTS The calibtration curve linear of fursultiamine hydrochloride,pyridoxamine dihydrochloride and vitamin B12 were 2.04-20.4 μg,2.05-20.5 μg and 0.020 6-0.206 μg,respectively,which showed a good linear relationship(r=1.000,0.999 9,1.000).The average recoveries were 101.0%,101.6%,98.3%,respectively(n=9,RSD=0.50%,1.40%,0.30%).CONCLUSION The method is simple,accurate,repeatable and can be applied to determine the content of fursultiamine hydrochloride,pyridoxamine dihydrochloride and vitamin B12 in compound trivitamin B injection.