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
杜碧莹
DU Bi-ying (Guangzhou Institute of Drug Control
摘要(Abstract):
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.
关键词(KeyWords):
注射用水溶性维生素;维生素B12;含量测定
water-soluble vitamins;vitamin B12;content assay
基金项目(Foundation):
作者(Author):
杜碧莹
DU Bi-ying (Guangzhou Institute of Drug Control