HPLC法测定注射用甲硫氨酸维B_1有关物质

Determinnation of Related Substances in Methionine and Vitamin B_1 for Injection by HPLC

目的:测定注射用甲硫氨酸维B_1中有关物质的方法。方法:采用高效液相色谱法,色谱柱C_(18)ODS-1,Kromasil,4.6mm×250mm,流动相为甲醇-乙腈-0.020mol/L庚烷磺酸钠溶液(含1%三乙胺溶液)(用磷酸调pH值至5.5)(9:9:82)。检测波长:220nm,流速1mL/min。结果:甲硫氨酸与维B_1及其二者降解产物能有效分离,甲硫氨酸最低检出量为22ng,维生素B_1最低检出量为10ng,注射用甲硫氨酸维B_1成品控制总杂质不超过1.5%。结论:本法准确、简便、专属,适用于注射用甲硫氨酸维B_1的有关物质检查。

Objective：To establish a HPLC method for determination of related substances in Methionine and Vitamin B1 for Injection. Methods ： The HPLC system consisted of ODS - 1, Kromasil - C18 column （ 4. 6nm × 250nm ）, methanol - acetonitrile - 0. 020mol/L Sodium 1 -Heptanesulfonate （9： 9： 82） （contain 1% trithylamine ）, adjusting pH to 5.5 with phosphate, as mobile phase. The flow rate was 1 ml/min. The detection wavelength was 220nm. Results： A satisfactory separation condition among the related impurities and the .sample was obtained. The LOD of Methionine was 22ng and VitaminB1 was 10 ng. The total impurities were not more than 1.5%. Conclusion： This method can be used for the impurity control of Methionine and Vitamin B1 For Injection and it was at.curate ,simple and specific.