HPLC测定利可君原料药中主药含量和有关物质

 目的研究HPLC测定利可君原料药和有关物质的方法。方法采用Phenomnex Luna C₁₈色谱柱(4.6 mm×250 mm,5μm);以水-乙腈-冰醋酸(62∶38∶0.3)为流动相;流速1.0 mL·min^-1;检测波长210 nm,外标法(以4种非对映异构体峰面积之和计)测定利可君含量,峰面积归一化方法测定有关物质。结果利可君的线性范围为2.0～200 mg·L^-1,r=0.999 7;检出限为0.50 mg·L^-1;最低定量限为2.0 mg·L^-1;利可君在流动相溶液中6 h内稳定,精密度良好。结论本法简便,快速,准确,可适用于利可君原料药含量和有关物质的测定。

Study on Determination of Leucogen and Its Related Substance by HPLC

OBJECTIVE To establish a HPLC method for the determination of leucogen and its related substance.METHODS A Phenomnex Luna C₁₈(4.6 mm×250 mm,5 μm) was used with a mobile phase consisting of water-acetonitrile-glacial acetic acid(62∶38∶0.3).The detection wavelength was 210 nm and the flow rate was 1.0 mL·min^-1.The quantitative determination of leucogen was performed with external standard method using total area of its four diastereomers,and its related substance was determined by normalization method.RESULTS The linearity of the determination by HPLC was over the range of 2.0～200 mg·L^-1;the correlation coefficient was 0.999 7;the LOD was 0.50 mg·L^-1;the LOQ was over the range of 2.0 mg·L^-1;the sample solution was stable within 6 h;the precision was good.CONCLUSION The HPLC assay and related substance test method is simple and accurate.