【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%。更多还原

【Abstract】 HPLC was applied to the determination of Roflumilast and 4impurities in Roflumilast drug.The sample was dissolved with acetonitrile.Welch Ultimate XB-C18 chromatographic column was used as stationary phase,and a mixture of 0.01mol·L-1 K2HPO4solution(adjusted pH to 4with 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 4impurities 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%.更多还原