HPLC法测定琥乙红霉素口服制剂中红霉素残留量  

Determination of Erythromycin in the oral preparations of Erythromycin ethylsuccinate by HPLC

作　　者：佟志[1] 钟长鸣 王庆全 

机构地区：[1]南昌大学第一附属医院,南昌330006 [2]江西省食品药品检验所,南昌330006

出　　处：《药品评价》2005年第6期434-435,共2页Drug Evaluation

摘　　要：目的建立琥乙红霉素口服制剂中红霉素残留量的检测方法。方法采用HamilT&NRP-1 L21(250mm×4.6mm)色譜柱,柱温:60℃,磷酸盐缓冲液(0.067mol.L-1,pH9.0)―乙晴―叔丁醇―水(453∶51∶28∶)为流动相,流速:0.8ml.min-1,检测波长:215nm,进样量:100μL。结果红霉素在300u.ml-1～3000u.ml-1范围内呈良好线性关系(r=0.9995),平均回收率为103.7%,RSD为1.1%,最低检测限为1.5u。结论该法专属性强,灵敏度高,重现性较好,可作为琥乙红霉素口服制剂中红霉素残留量的测定方法。Objective To develop HPLC method for the determination of Erythromycin in oral preparations of Erythromycin ethylsuccinate. Methods The column：HamilT＆NRP-1 L21（250mm× 4.6mm）;The column temperature：60℃;The mobile phase：0.067mol.L^-1 phosphate buffer with pH9.- acetonitrile - 2-Methyl-2-Propanol- Water （45 ： 35 ： 12： 8） ;The flow rate 0.8ml·min^-1;The detection Wavelength：215nm;The injection volumn 100ul; Results The linear range of Erythromycin was 300～3000u·ml^-1,r=0.9995, The mean recovery was 103.7%,and the RSD was 1.1%,The detection limit was 1.5u. Conclusion The method is simple,highly sensitive and well reproducible and is suitable for the determination of Erythroycin in oral preparations of Erythromycin ethylsuccinate.

关 键 词：琥乙红霉素 红霉素残留量色谱法 高效液相 

分 类 号：R927[医药卫生—药学]