摘要
本文探讨了HPLC法测定伊曲康唑片的含量及其有关物质。采用Diamonsil^C18色谱柱；乙腈-磷酸二氢钾（0．01mol·L^-1磷酸二氢钾的水溶液，含0．2％三乙胺，用磷酸调pH至3．5）（65：35）为流动相；检测波长：261nm；流速：1ml·min；伊曲康唑与其相邻杂质峰能完全分离，伊曲康唑在0．174～348．8μg·ml。浓度范围内线性关系良好，r^2=0．9999。平均回收率100．2％，RSD为0．76％。该法简便、准确、专属性好，可以用于伊曲康唑片的含量测定及有关物质检查。
A HPLC method was established for determination of itraconazole and its related substances in itraconazole tablets. A Diamonsil C18 column was used with acetonitrile and potassium dihydrogen phosphate （0.01mol· L^-1 water solution, with 0.2% triethylamine, pH was adjusted to 3.5 by phosphoric acid） （65： 35） as mobile phase. The flow rate was 1ml· min^-1 and detecting wavelength was 261nm. hraonazole could be completely separated from interfacing impurity peaks. The linear range of itraconazole was between 0. 174 and 348.8 μg · ml^-1 , r^2 =0. 9999. The method was simple, accurate and specific. It could be used in the determination of itraconazole and its related substance in hraconazole tablets.
出处
《中国药事》
CAS
2006年第1期41-43,共3页
Chinese Pharmaceutical Affairs
