RP-HPLC法测定氯霉素及注射液的有关物质和含量  

Determination of Chloramphenicol and its Injection and Related Substances by RP-HPLC

作　　者：陈宁林 

机构地区：[1]湖北省药品检验所,武汉430064

出　　处：《中国药品标准》2004年第6期47-50,共4页Drug Standards of China

摘　　要：目的:采用 RP-HPLC 法测定氯霉素及注射液的有关物质和含量。方法:用 Kromasil C_(18)色谱柱(10μm,4.6mm×200mm),以[0.1%庚烷磺酸钠溶液-二甲基甲酰胺-冰醋酸(500:5:0.5),pH3.2]-乙腈(70:30)为流动相;检测波长为272nm;流速为1.0ml·min^(-1)。结果:氯霉素在0.02～1mg·ml^(-1)范围内呈良好的线性关系,回归方程为 Y=16813344X+5465(r=0.9999),氯霉素二醇物在1～40μg·ml^(-1)范围内呈良好的线性关系,回归方程为 Y=54695X+541(r=0.9999);平均回收率为99.3%,RSD=0.5%(n=5)。结论:所用方法简便、准确、专属性好,可用于氯霉素及注射液的二醇物检测和氯霉素的含量测定。Objective:Toestablish a RP-HPLC method for the determination of Chloramphenicol and its Injection and related substances.Method:Kromasil C_(18)column(200mm×4.6mm,10μm),[0.1% sodium heptanesulfonate-N,N-dimethylformamide- glacial acetic acid(500:5:0.5)pH3.2]-acetonitrile(70:30)as mobile phase,the detection wavelength was 272nm,the flow rate was 1.0ml·min^(-1).Results:The calibration curves was linear in the concentration range of 0.02～1mg·ml^(-1)for Chlo- ramphenicol.The regression equation:Y=16813344X+5465(r=0.9999),the calibration curve was linear in the concentration range of 1～40g·ml^(-1)for 1-p-nitropheny-2-amino-1,3-propanediol.The regression equation:Y=54695X+541(r=0.9999); The average recovery was 99.3%,RSD=0.5%(n=5).Conclusions:This method was found to be simple,quick and accurate for the simultaneous separation and determination of Chloramphenicol and its injection and related substances.

关 键 词：氯霉素 注射液 RP-HPLC法 有关物质 二醇物 含量测定 RSD 磺酸 乙腈 平均回收率 

分 类 号：R927.2[医药卫生—药学] R286.0