摘要
建立了高效液相色谱法测定阿戈美拉汀的有关物质,采用Inertsil C18色谱柱,以0.01 mol/L十二水合磷酸氢二钠溶液（用磷酸调至pH 2.7）∶甲醇∶乙腈（40∶35∶25）为流动相A,乙腈为流动相B,梯度洗脱,检测波长230 nm。阿戈美拉汀与各有关物质分离完全,且在0.030-0.225μg/ml范围内线性关系良好,平均回收率为102.0%-102.6%,RSD为1.07%-1.77%。
An HPLC method was established for the determination of related substances in agomelatine. An Inertsil C18 column was used, with the mobile phase A of 0.01 mol/L disodium phosphate dodecahydrate solution （adjusted to pH 2.7 with phosphoric acid）∶methanol∶acetonitrile（40∶35∶25）, and the mobile phase B of acetonitrile for gradient elution, at the detection wavelength of 230 nm. Agomelatine and its related substances were seperated well, and their calibration curves were linear in the concentration ranges of 0.030—0.225 μg/ml. Their average recoveries were 102.0%—102.6%, with RSDs of 1.07%—1.77%.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2016年第10期1298-1301,共4页
Chinese Journal of Pharmaceuticals
作者简介
罗钧秋（1984-），女，执业药师，从事药品质量标准研究。Tel：17749769565E-mail：ljqxf841019@163.com
