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

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

关键词:  高效液相色谱法  注射用复方三维B  盐酸呋喃硫胺  盐酸吡多胺  维生素B₁₂

Key words:  HPLC  compound trivitamin B injection  fursultiamine hydrochloride  pyridoxamine dihydrochloride  vitamin B₁₂

摘要:

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，5 μm)，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220 nm，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2.04~20.4 μg，2.05~20.5 μg，0.020 6~0.206 μg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。

Abstract:

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.