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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: To determine the content of vitamin B1 and its related substances in methionine and vitamin B1 injection by reversed-phase high performance liquid chromatography. Methods: The mobile phase consisted of Luna C18 (4.6 mm × 150 mm, 5 μm) column, acetonitrile-methanol-0.005 mol·L-1 sodium glacial acetic acid solution (16:24:60) 1.0mL.min-1, detection wavelength of 254nm; column temperature: room temperature. Results: The linearity of vitamin B1 in the range of 0.1604-3.208μg (r = 0.9999) was good. The average recoveries were 99.7%, 99.7% and 100.3%, respectively, with RSDs of 1.1%, 1.0% and 0.69%, respectively 3). The limit of detection was calculated as 3.3ng for vitamin B1 and the limit of quantification was 11.0ng. Conclusion: This method is used to determine the content of vitamin B1 in methionine and vitamin B1 injection and its related substances. The method is simple and convenient, the specificity is good and the result is accurate.