HPLC法测定盐酸美西律中有关物质

目的：建立HPLC法测定盐酸美西律中有关物质.方法：采用Agela C18色谱柱（250 mm×4.6mm,5 μm）,以甲醇-0.1 mol·L-1醋酸钠（50：50）为流动相（用冰醋酸调节pH至5.8±0.1）,流速为1.0 ml·min-1 检测波长为262nm.结果：降解产物与主峰均分离良好 盐酸美西律最低检测限为14 ng,已知杂质2,6-二甲基酚最低检测限为0.3 ng.结论：该法专属性强,准确,灵敏,可用于盐酸美西律原料中有关物质的检查.

Determination of the Related Substances of Mexiletine Hydrochloride by HPLC

Objective： To established an HPLC method to determine the related substances in mexiletine hydrochloride. Method： The Agela C18 column （250 mm ×4. 6 mm,5 μm） was used and the mobile phase consisted of methanol-0, lmol-L-1 natrium acetate （ 50： 50） （ with ghaeial acetic acid adjust pH to 5.8 ±0. 1 ） , with flow rate Was 1.0 ml. min - 1 and the detection wavelength at 262 nm. Result： The resolution between the peak of mexiletine hydrochloride and other peaks was good;the limit of detection of mexiletine hydroehloride was 14 ng, the limit of detection of 2,6-dimethylphenol was 0. 3 ng. Conclusion： The method is specific, accurate, sensi- tive and can be used for determining the related substances of mexiletine hydrochloride.