【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),
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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 establish a HPLC method for the determination of related substances in mexiletine hydrochloride. Methods: The mobile phase consisted of Agela C 18 column (250 mm × 4.6 mm, 5 μm) and methanol-0.1 mol·L -1 sodium acetate (50:50) (adjusted to pH 5.8 with glacial acetic acid ± 0.1), the flow rate was 1.0 ml · min -1 and the detection wavelength was 262 nm. Results: The degradation products were separated from the main peak. The detection limit of mexiletine hydrochloride was 14 ng, and the detection limit of 2,6-dimethylphenol was 0.3 ng. Conclusion: The method is highly specific, accurate and sensitive and can be used for the examination of related substances in the raw materials of mexiletine hydrochloride.
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