高效液相色谱法测定注射用哌拉西林钠他唑巴坦钠主药及杂质的含量  

Determination of the main medicine and impurities in injectable piperacillin sodium and tazobactam sodium by HPLC

作　　者：田力[1] 祝红杰[1] 

机构地区：[1]大连医科大学附属第一医院,大连116011

出　　处：《实用药物与临床》2011年第6期490-491,共2页Practical Pharmacy and Clinical Remedies

摘　　要：目的考察3个厂家生产的注射用哌拉西林钠他唑巴坦钠的主药和杂质的含量。方法采用Hypersil BDS-C18色谱柱(4.6 mm×250 mm,5μm),甲醇∶四丁基氢氧化铵水溶液(pH 3.5,50∶50)为流动相,流速0.8 mL/min,检测波长为220 nm,室温下进行检测。结果 3种样品的哌拉西林含量分别为标示量的102.8%、96.4%、103.1%;他唑巴坦含量分别为标示量的99.8%、93.3%、98.1%;杂质的含量分别为1.72%、2.74%、1.85%。结论本实验结果表明,3个厂家生产的注射用哌拉西林钠他唑巴坦钠的主药与杂质的含量均符合药典规定。Objective To determine the content of the main drugs and impurities in injectable piperacillin sodium and tazobactam sodium of three manufacturers.Methods The chromatographic column was Hypersil BDS C18（4.6 mm×250 mm,5 μm）,the mobile phase was methanol and tetrabutyl ammonium hydroxide（pH 3.5,50∶ 50）at a flow-rate of 0.8 mL/min,the detection wavelength was 220 nm at room temperature.Results The content of piperacillin sodium in three sample solutions were 102.8%,96.4%,103.1% respectively.The content of tazobactam sodium in three sample solutions were 99.8%,93.3%,98.1% respectively.The content of impurities in three sample solutions were 1.72%,2.74%,1.85%.Conclusion The contents of piperacillin sodium,tazobactam sodium and impurities in the products of three manufacturers are in accordance with the related requirements of the Chinese Pharmacopoeia.

关 键 词：哌拉西林钠 他唑巴坦钠 杂质 HPLC 

分 类 号：R927[医药卫生—药学]