HPLC法对氯霉素注射液中氯霉素及二醇物的含量测定  

Determination of Chloramphenicol Injection and its Related Substances by HPLC

作　　者：黄秀凤[1] 邓洲达 

机构地区：[1]广西北海食品药品检验所,536000 [2]广西桂林医学院实习生,536000

出　　处：《中外健康文摘：医药月刊》2007年第8期19-21,共3页

摘　　要：目的 建立对氯霉素注射液中氯霉素及降解物二醇物含量测定的高效液相色谱法，以满足质量控制的要求。方法 在ODS（4.6mm×250mm，5μm）色谱柱上，以甲醇-乙腈-0.1％庚烷磺酸钠-冰醋酸（40∶5∶55∶0.2）为流动相，于272nm波长处检测，流速为1ml／min。结果 氯霉素在43.06～258.38μg/ml浓度范围内呈良好的线性关系，回归方程为：Y=33913539.2X＋23757.5（r=O.99999 n=6），二醇物在9.78～58.68μg/ml浓度范围内呈良好的线性关系，回归方程为：Y=60698075.9X-713.2（r=O.99999 n=6）。精密度RSD为0.05％（n=5）。氯霉素的平均回收率为99.57％，RSD为0.81％，二醇物的平均回收率为99.14％，RSD为0.38％。结论 本法可同时测定氯霉素注射液中氯霉素与氯霉素二醇物的含量，为质量控制提供依据,而且方法简便、快速,结果准确可靠。Objective： To establish an HPLC method for determination of Chloramphenicol Injection and its related substances 2-amino-l-（4-nitrophenyl）-l, 3-diol. Method： ODS （4.6mm×250mm, 5μm）column ,the mobile phase was methanol-acetonitrile-O.1% sodiumheptanesulfonate-glacial acetic acid （40： 5： 55： O.2）, the detective wavelength was 272nm, the flow rate was about 1ml/min. Result： The calibration curves was linear in the concentration range of 43.06-258.38μg/ml for Chloramphencol, The regressione quation： Y=33913539.2X＋23757.5（r=O.99999 n=6）;The calibration curves was linear in the concentration range of 9.78-58.68μg/ml for 2-amino-1- （4-nitrophenyl） -1, 3-diol, The regressione quation： Y=60698075.9X-713.2（r=O.99999 n=6）. the average recovery of Chloramphenicol were 99.57%, RSD=O.81%, the average recovery of 2-amino-l-（4-nitrophenyl）-l, 3-diol were99.14%, RSD=O.38% . Conclusions： This method was found to be simple, quick and accurate for the simuItaneous separation and determination of Chloramphenicol and its related substances.

关 键 词：氯霉素 氯霉素二醇物 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]