甲硫氨酸维B1注射液中维生素B1的有关物质及含量的测定___

目的：采用反相高效液相法测定甲硫氨酸维B1注射液中维生素B1的含量及其有关物质。方法：采用Luna C18(4.6 mm×150 mm，5 μ m)色谱柱 以乙腈-甲醇-0.005 mol•L-1辛烷磺酸钠的1%冰醋酸溶液（16∶24∶60）为流动相 流速为1.0 mL•min-1，检测波长为254 nm 柱温：室温。结果：维生素B1在0.1604～3.208 μg( r=0.9999)范围内线性关系良好 平均加样回收率分别为99.7%，99.7%，100.3%，RSD分别为1.1%，1.0%，0.69%(n=3)，检测限以维生素B1计算为3.3 ng，定量限为11.0 ng。结论：本法用于测定甲硫氨酸维B1注射液中维生素B1的含量和有关物质，方法简便，专属性好，结果准确。

Objective:A RP-HPLC method was established for the determination of vitamin B1 and its related substances in methionine and vitamin B1 injection.Method:The separation was performed on a Luna C18 (150 mm×4.6 mm,5 μm) column.The mobile phase was composed of acetonitrile-methanol-0.005 mol•L-1 sodium octanesulfonate and 1% glacial acetic acid(16∶24∶60).The flow rate was 1.0 mL•min-1,the detection wavelength was 254 nm,the temperature of the column was conducted at room temperature.Result:the calibration curves were linear between 0.1604-3.208 μg( r=0.9999).The average recovery was 99.7%，99.7%，100.3%，RSD were 1.1%，1.0%，0.69%(n=3).Conclusion:The method is simple,rapid,accurate and suitable for the determination of Vitamin B1 and its related substances in methionine and vitamin B1 injection.