Shakalisava Yuliya, Regan Fiona
School of Chemical Science, Dublin City University, Dublin, Ireland.
J Sep Sci. 2008 Apr;31(6-7):1137-43. doi: 10.1002/jssc.200700591.
This work verifies the potential of CE in the analysis of significant impurities of montelukast sodium - an active ingredient for the treatment of bronchial asthma. Using 20 mM borate buffer pH 9.2 with 10 mM SDS and 10 mM (2-hydroxypropyl)-gamma-CD (2HP-gamma-CD) it was possible to separate montelukast and several impurities, including its cis-isomer, after exposure to light and oxygen. The obtained method surpasses a chromatographic method for montelukast sodium in terms of time of analysis (9 min of CE analysis vs. 35 min HPLC) and efficiency (CE offered over 900 000 theoretical plates for montelukast). Good repeatability of the method was supported by the low % RSD for the migration time of montelukast (0.53%). For the first time, the capillary electrophoretic method was employed for temporal study of the degradation of montelukast. The results showed that degradation of montelukast and the formation of the cis-isomer mainly occurred during the first 2 days of exposure, and occurred to a higher degree when there was no contact with the air (oxygen) in the exposed sample.
这项工作验证了毛细管电泳（CE）在分析孟鲁司特钠（一种治疗支气管哮喘的活性成分）的重要杂质方面的潜力。使用pH 9.2的20 mM硼酸盐缓冲液，添加10 mM十二烷基硫酸钠（SDS）和10 mM（2-羟丙基）-γ-环糊精（2HP-γ-CD），在光照和氧气作用后，能够分离孟鲁司特及其几种杂质，包括其顺式异构体。所获得的方法在分析时间（CE分析9分钟，而高效液相色谱法（HPLC）为35分钟）和效率（CE为孟鲁司特提供了超过900000的理论塔板数）方面优于孟鲁司特钠的色谱分析方法。孟鲁司特迁移时间的低相对标准偏差（RSD）为0.53%，支持了该方法良好的重复性。首次采用毛细管电泳法对孟鲁司特的降解进行了时间研究。结果表明，孟鲁司特的降解和顺式异构体的形成主要发生在暴露的前2天，并且在暴露样品中不与空气（氧气）接触时发生的程度更高。
