注射用水溶性维生素中维生素B_(12)含量测定方法改进

Improvement of Assay Method for Vitamin B_(12) in Water-soluble Vitamins for Injection

目的建立高效液相色谱法,改进注射用水溶性维生素中维生素B12的含量测定方法。方法色谱柱为COSMOSIL C18(250mm×4.6mm×5μm),流动相为甲醇-水(25∶75);流速为1.2ml/min;柱温为30℃,检测波长为550nm。结果维生素B12在每毫升含0.25～0.75μg的浓度范围内线性关系良好,r=0.9998(n=5)。平均回收率为99.2%,相对标准偏差值(RSD)为0.8%(n=9)。结论本方法简便、准确,不受其他成分的干扰,可用于测定注射用水溶性维生素中维生素B12的含量。

Objective To establish an HPLC method to improve the content assay method for vitamin B12 in water - soluble vitamins for injection. Methods COSMOSIL C18 （250 mm ×4. 6 mm,5 μm） was used as the column. The mobile phase was consisted of methanol - water （25 ： 75）. The flow rate was 1.2 ml/min, the column temperature was 30℃ and the detection wavelength was 550 nm. Results Vitamins B12 presented a good linear ship in the range of 0. 25 -0. 75 μg,r =0. 9998 （n = 5）. The average recovery was 99. 2%,RSD =0. 8% （n =9）. Conclusion The present method is simple and accurate for the content determination of vitamin B12 in water-soluble vitamins for injection, and it also has the advantage of preventing the interference from other compounds.