高效液相色谱法测定罗氟司特药品中罗氟司特和4种杂质  

HPLC Determination of Roflumilast and 4 Impurities in Roflumilast Drug

作　　者：杨丽霞[1] 闫建军[2] 冯彩婷[1] 

机构地区：[1]周口师范学院化学化工学院,周口466001 [2]周口师范学院学报编辑部,周口466001

出　　处：《理化检验（化学分册）》2015年第5期594-596,共3页Physical Testing and Chemical Analysis(Part B:Chemical Analysis)

基　　金：河南省基础与前沿技术研究计划项目资助(132300410478)

摘　　要：提出了高效液相色谱法测定罗氟司特药品中罗氟司特和4种杂质。样品以乙腈溶解,采用Welch Ultimate XB-C18色谱柱为分离柱,以0.01mol·L-1磷酸氢二钾溶液（用磷酸调节pH为4.0）与乙腈以体积比50比50组成的混合溶液为流动相,在检测波长215nm处进行测定。罗氟司特和4种杂质在一定的质量浓度范围内与其峰面积呈线性关系。方法的测定下限（10S/N）在0.04~0.22ng之间。加标回收率在101%~102%之间,测定值的相对标准偏差（n=9）均小于2.0%。HPLC was applied to the determination of Roflumilast and 4 impurities in Roflumilast drug. The sample was dissolved with acetonitrile. Welch Ultimate XB-C18 chromatographic column was used as stationary phase, and a mixture of 0. 01 mol · L-1 K2HPO4 solution （adjusted pH to 4 with phosphoric acid） and acetonitrile （50＋50） was used as mobile phase. UV-detection at 215 nm was adopted in the determination. Linear relationships between values of peak area and mass concentration of Roflumilast and the 4 impurities were kept in definite ranges. Low limits of determination （10S/N） found were ranged from 0. 04 to 0. 22 ng. Values of recovery found by standard addition method were in the range of 101%-102%, and values of RSD＇s （n=9） less than 2.0%.

关 键 词：高效液相色谱法 罗氟司特 药品 杂质 

分 类 号：O652.63[理学—分析化学]