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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。
OBJECTIVE To establish an HPLC method for the determination of fuflin sulfate, pyrimethanil hydrochloride and vitamin B12 in compound three-dimensional B for injection. Methods The column C18 (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of heptane sulfonate solution - acetonitrile - methanol. The gradient elution was performed at a flow rate of 1.0 mL · min 1. The detection wavelength was 220 nm. Piroxicam hydrochloride peak count of not less than 3 000, the column temperature was 30 ℃. Results Furan thiamine hydrochloride, pyridoxamine hydrochloride and vitamin B12 showed good linear relationship with the peak area in the range of 2.04 ~ 20.4μg, 2.05 ~ 20.5μg, 0.020 6 ~ 0.206μg respectively (r = 1.000,0.999 9,1.000, respectively) The average recoveries were 101.0%, 101.6% and 98.3%, respectively (n = 9, RSD 0.5%, 1.4% and 0.3%, respectively). Conclusion This method is simple, accurate and reproducible. It is suitable for the determination of Furan thiamine hydrochloride, Pyridoxine Hydrochloride and Vitamin B12 in Compound B 3D for Injection.