反相高效液相色谱法测定注射用哌拉西林钠/舒巴坦钠的含量  

Determination of piperacillin and sulbactam sodium in compound injection by RP-HPLC

作　　者：闫小燕[1] 胡欣[1] 曹国颖[1] 何笑荣[1] 殷琦[1] 

机构地区：[1]卫生部北京医院,北京100730

出　　处：《中国医院药学杂志》2003年第1期33-35,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :建立注射用哌拉西林钠 /舒巴坦钠的含量及有关物质测定方法。方法 :采用C18柱 ,流动相为 :甲醇 0 .2moL·L-1磷酸二氢钾溶液 10 %四丁基氢氧化铵溶液 水 (5 10∶5 0∶8∶432 ) ,pH4.1,检测波长为 2 30nm ,流速 0 .8mL·min-1。结果 :线性范围为舒巴坦 5 .1～ 6 0 6 .3mg·L-1,哌拉西林 13 .2～ 15 83.1mg·L-1,回收率哌拉西林为 (99.6± 0 .5 ) % ,舒巴坦 (10 0 .2±0 .8) % ,最低检测限为 2 .2 2ng和 0 .94ng。结论 :本法简便、专属、重现性好 ,可同时测定哌拉西林和舒巴坦含量 ,亦可用于有关物质检查。OBJECTIVE To develop a method for the determination of piperacillin and sulbactam sodium for injection.METHODS An HPLC method was used with C 18 column ( 5 μm, 4.6 mm×250 mm);The mobile phase was a mixture of methanol- 0.2 mol.L -1 monobasic sodium phosphate-10% tetrabutylammonium hydroxide-water(510∶50∶8∶432),adjusted with 10% phosphoric acid to a pH of 4.1,with the detection wavelength at 230 nm.RESULTS The precision and stability were fine.The linear correlation of piperacillin and sulbactam were observed over the concentrations 5.1 to 606.3 mg·L -1 (r= 1.000) and 13.2 to 1583.1 mg·L -1 (r= 0.9999) respective.The average recoveries of piperacillin and sulbactam were ( 99.6± 0.5)% and ( 100.2± 0.8)% respective.The resolution between the respective peaks of piperacillin an sulbactam and the other peaks conformed to the requirements.CONCLUSIONS The method is convenient,selective and reproducible for the simultaneous assay of piperacillin and sulbactam.

关 键 词：哌拉西林 舒巴坦 高效液相色谱法 含量 

分 类 号：R927.2[医药卫生—药学]