甲硫氨酸维B_1注射液中维生素B_1的有关物质及含量的测定

RP-HPLC determination of vitamin B_1 and related substances in methionine and vitamin B_1 injection

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(4.6mm×150mm,5μm)色谱柱;以乙腈-甲醇-0.005mol·L-1辛烷磺酸钠的1%冰醋酸溶液(16∶24∶60)为流动相;流速为1.0mL.min-1,检测波长为254nm;柱温:室温。结果:维生素B1在0.1604～3.208μg(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3.3ng,定量限为11.0ng。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×150mm,5μm） 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.