摘要
目的:建立抗精神分裂药物佐替平原料中有关物质的测定方法。方法:采用高效液相色谱法,色谱系统为:Phenom enex C18色谱柱,流动相为0.05 mol.L-1乙酸铵(用三乙胺调节pH7.0)-乙腈(20∶80),检测波长260 nm。结果:佐替平主峰与有关物质峰均分离良好;3批样品中杂质峰面积之和均未超过对照液主峰面积。结论:本法专属性强,能够有效控制佐替平原料的质量。
Objective： The purpose is to determine the related substances in zotepine, a antischizophrenia drug. Method： A Phenomenex C18 column was used with the mobile phase of 0. 05 mol·L^-1 ammonium acetic（added triethylamine to adjust pH7. 0）- acetonitrile （20： 80） at the detection wavelength of 260 nm. Result： All the chief peaks of zotepine and those of their related substances could be well isolated. The total peak area of the impurity of all the 3 batches of samples were no more than the chief peak area of reference solution. Conclusion： It is a good method to control the quality of zotepine.
出处
《药学与临床研究》
2008年第6期518-519,共2页
Pharmaceutical and Clinical Research
