高效液相色谱法测定利福霉素钠含量与有关物质  

Determination of rifamycin sodium and related substances content by HPLC

作　　者：刘英 张磊 崔春英 杨淑先 

机构地区：[1]河南省药品检验所,郑州450003 [2]郑州大学药学院,郑州450052

出　　处：《中国抗生素杂志》2005年第2期84-87,共4页Chinese Journal of Antibiotics

摘　　要：目的建立高效液相色谱法测定注射用利福霉素钠含量及其有关物质的方法。方法色谱柱AlltechAlltimaC18(250mm×4.6mm,5μm);柱温35℃;流动相甲醇∶乙腈∶0.075mol/L磷酸二氢钾溶液∶1.0mol/L柠檬酸溶液(33∶33∶31∶4);流速1.0ml/min;检测波长254nm;进样量10μl。结果利福霉素的线性范围为0.01mg/ml～4.50mg/ml,r=1.0000,日内RSD为0.2%,日间RSD为0.1%～0.2%,平均回收率为99.7%(n=9),最低检测限为5.4ng。结论本方法简便快速,专属性好,精密度高,准确可靠,可作为控制利福霉素钠与注射用利福霉素钠含量及其有关物质质量的分析方法。Objective A high performance liquid chromatography method was established for the determination of rifamycin sodium and related substances content. Method The analytical column was Alltech Alltima C_~18 (250mm×4.6mm, 5μm). The mobile phase was a mixture of methanol∶acetonitrile∶0.075mol/L potassium dihydrogen phosphate solution∶and 1.0 mol/L citric acid (33∶33∶31∶4). The flow rate is 1.0 ml/min, the detection wavelength was 254 nm and the injection volume was 10μl. Results The calibration curve for rifamycin was linear in the range from 0.01mg/ml to 4.5mg/ml, r=1.0000. The precision was 0.2%, the inter-day RSD was 0.1% to 0.2% and the average recovery rate was 99.7% (n=9), the detection limit was 5.4ng. Conclusion The method was convenient, specific, accurate and reproducible for the assay of ~rifamycin sodium and it′s preparation.

关 键 词：高效液相色谱法 利福霉素钠 含量测定 有关物质 

分 类 号：R978.1[医药卫生—药品]