利福昔明含量测定及其有关物质检测方法的研究  

Study on the Determination of Assay and Related Compounds in Rifaximin

作　　者：赫爱平 张亚杰 赵晓冬 孙长山[2] 

机构地区：[1]辽宁省药品检验所抗生素室,110023 [2]沈阳药科大学药学院,110016

出　　处：《中国药品标准》2004年第5期21-23,共3页Drug Standards of China

摘　　要：本文采用高效液相色谱法对利福昔明原料的含量测定及有关物质进行了研究。固定相为辛基硅烷键合硅胶,流动相为甲醇-0.075mol／L磷酸二氢钾溶液-1.0mol／L枸橼酸溶液(50:28:6),检测波长为254nm。利福昔明的线性回归方程及线性范围分别为Y=27399X+12300(r=0.9999),0.76-149μgmg／ml;溶液在8小时内稳定(RSD=0.12%);定量限为0.8ng,检测限为0.25ng;精密度RSD=0.09%;重现性RSD=1.0%;本系统的耐用性良好。High performance liquid chromatographic method was developed for the determination of assay and related compounds in Rifaximin. Octyl silane bonded silica was used as stationary phase,and mobile phase was methanol-0. 075mol/L potassium dihydrogen phosphate-0. 1mol/L citric acid (50: 28 :6). Detection wavelength was 254nm. The regression equation of rifaximin was Y= 27399X + 12300(r = 0. 9999),with linear range of 0. 76-149μg/ml. Test solution was stable within 8 hours(RSD=0. 12%). Limit of quantity was 0. 8ng and limit of detection 0. 25ng. Relative standard deviation for precision was 0. 09% and 1. 0% for reproduction. The system has good tolerance.

关 键 词：利福昔明 有关物质 含量测定 RSD 枸橼酸 高效液相色谱法 检测限 硅烷 甲醇 重现性 

分 类 号：R927[医药卫生—药学] R978.1