尼麦角林中有关物质的检查

Determination of related substances in nicergoline

建立尼麦角林原料药中有关物质的检查方法.采用高效液相色谱法,以SymmertyC18色谱柱(250×4.6mm,10μm),甲醇-30mmol.L-1KH2PO4水溶液-三乙胺(61:39:0.8,磷酸调节pH3.5±0.1)为流动相,流速1.0mL.min-1,在波长287nm处对尼麦角林进行有关物质检查.对已知杂质1-MMDL采用加校正因子的主成分自身对照法检查,对未知杂质采用不加校正因子的自身对照法检查.该方法专属性强,灵敏度高,精密度好,准确可靠,可用于质量控制.

The related substances in sample are determined on the HPLC instrument fixed a Symmerty ODS C18 column(250mm×4.6mm,10μm).The mobile phase consists of potassium dihydrogen phosphate(0.03mol.L-1),methyl alcohol and triethylamine(69: 31: 0.8,adjusted to pH3.5 ± 0.1 with phosphoric acid) at a flow rate of 1.0 mL.min-1.The detective wave-length is 287 nm.1-MMDL as the known related substances are determined with correction factors and the others are detected with no correction factors.This method is specific,sensitive,accurate and suitable for the quality control for nicergoline.