摘要
目的:建立HPLC法测定盐酸美西律中有关物质。方法:采用Agela C_(18)色谱柱(250 mm×4.6 mm,5μm),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。
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.
出处
《中国药师》
CAS
2010年第6期811-812,共2页
China Pharmacist
