HPLC法测定铃兰欣的含量  

Determination of the Content of Linglanxin by HPLC

作　　者：高英丽[1] 蓝守彬[1] 

机构地区：[1]哈药集团制药总厂,150086

出　　处：《黑龙江医药》2005年第2期10-12,共3页Heilongjiang Medicine journal

摘　　要：目的:用高效液相色谱法同时测定复合制剂铃兰欣成分注射用头孢哌酮钠和舒巴坦钠的含量。方法:本法以外标法为基础,色谱务件:以 ODS—3反相柱作为分析柱,流动相组成为0.005mmol/L 四丁基氢氧化铵-乙腈(825:175,V/V),磷酸调整 PH=5.0,流速为1.2ml/min,再自外检测器272nm 进行检测。结果:本法注射用头孢哌酮钠和舒巴坦钠的最低检出浓度分别为10mg/L 和5mg/L,在20—1000mg/L 范围内呈线形,注射用头孢哌酮钠和舒巴坦钠的绝对回收率分别为99.4%～102.9%和95.0%—105.3%,批内和批间 RSD 分别为1.4%,1.5%和1.8%、1.9%。结论:此方法简便、快速、准确,可作为测定复合制剂铃兰欣含量方法。Objection:To establish a method for simultaneous determination of the content of linlanxin-cefoperazone sodium and sulbactam sodium for injection by HPLC.Methods:A HPLC has been established on ODS-3 column reversed -phase,with 0.067mol/L,the mobile phase consisted of tetrabuty lammonium hydroxide(0.005m mol/L)and acetonitrile (825:175,V/V),PH was adjusted to 5.0 with phosphoric acid.The flow rate was 1.2ml/min,and the detection was carried out with an ultraviolet detector(λ=272nm) .Result:The detection limits of cefoperazone sodium and sulbactam sodium for injection were respectively 10mg/L and 5mg/L.The lin- earity was in the range of 10-1000mg/L.The absolute recovery of cefoperazone sodium and sulbactam sodium for injection was respectively 99.4%-102.9% and 95.0%-105.3%.The between-day RSD of cefoperazone sodium and sulbactam sodium for injection was 1.4% and 1.5%,and intra-day RSD was 1.8 % and 1.9 % respectively.Conclusion:Tne method is simple and accurate,also as method for determination of linlanxin content.

关 键 词：注射用头孢哌酮钠 舒巴坦钠 含量 铃兰欣 HPLC法 复合制剂 检出 磷酸 外标法 流动相组成 

分 类 号：R927.2[医药卫生—药学] R978