HPLC法测定法罗培南钠含量及有关物质  

RP- HPLC assay of faropenem sodium and its related substances

作　　者：闫小燕[1] 胡欣[1] 何笑荣[1] 杨美琴[1] 

机构地区：[1]卫生部北京医院药剂科,北京100730

出　　处：《药物分析杂志》2006年第7期965-967,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立法罗培南钠的 HPLC 测定及有关物质检测方法。方法:采用 Phenomenex prodigy ODS 3色谱柱(150 mm×4.6 mm,5μm),流动相:磷酸盐缓冲液(取磷酸二氢钾4.8 g、磷酸氢二钠5.4 g 和溴化四丁基铵1.0 g,加水溶解,使成1000 mL)-乙腈(85:15),检测波长:305 nm,流速:1.0 mL·min^(-1),柱温:40℃。结果:法罗培南钠浓度在4.875～624μg·mL^(-1)范围内,与峰面积呈良好线性关系(r=1.000),其平均回收率±RSD 为(100.9±1.7)%,最低检测限为0.1 ng。结论:本法简便、专属,重现性好,可用于测定法罗培南钠含量及有关物质。Objective： To establish a method for the assay of faropenem sodium and its related substance. Methods： An HPLC method was adopted with C18 column（ 150 mm ×4. 6mm,5 μm） ;The mobile phase consisted of a mixture of phosphate buffer- acetonitrile （85：15 ）, with the detection wavelength at 305 nm. The column temperature was 40 ℃. Results： The precision and stability were fine. The linear correlation of faropenem sodium was observed over the concentrations 4. 875 to 624 μg · mL^-1 （r = 1. 000）. The average recoveries was （ 100. 9 ± 1.7）%. The resolution between the respective peaks of faropenem with the other peaks conformed to the requirements. Conclusion： The method is convenient, selective and reproducible for the assay of faropenem sodium and its related substance.

关 键 词：法罗培南钠 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]