他唑巴坦及其制剂注射用哌拉西林钠/他唑巴坦钠的HPLC含量测定方法的建立

The Establishment of Method for the Determination of Tazobactam and Tazocin(Piperacillin Sodium and Tazobactam Sodium for Injection)

目的：建立他唑巴坦及其制剂注射用哌拉西林钠／他唑巴坦钠的ＨＰＬＣ含量测定方法。方法：他唑巴坦的ＨＰＬＣ含量测定色谱条件：Ｃ１８柱，流动相：ｐＨ４０的乙腈－００５ｍｏｌ·Ｌ－１的磷酸二氢钾水溶液－２５ｍｍｏｌ·Ｌ－１四丁基氢氧化铵（１８０∶８０５∶１５），检测波长为２３０ｎｍ，流速：１ｍＬ·ｍｉｎ－１；注射用哌拉西林钠／他唑巴坦钠的ＨＰＬＣ含量测定色谱条件：Ｃ１８柱，流动相为ｐＨ３５的甲醇－水－２５ｍｍｏｌ·Ｌ－１四丁基氢氧化铵（４５０∶５３５∶１５），检测波长为２３０ｎｍ，流速：１ｍＬ·ｍｉｎ－１。结果：他唑巴坦的ＨＰＬＣ含量测定方法的线性范围为０１～３２ｍｇ·ｍＬ－１，日内ＲＳＤ为０３％，日间ＲＳＤ为０４２％～０６５％；注射用哌拉西林钠／他唑巴坦钠的ＨＰＬＣ含量测定方法中，他唑巴坦的线性范围为００５～１０ｍｇ·ｍＬ－１，日内ＲＳＤ为１１％，日间ＲＳＤ为１１％～１５％，哌拉西林的线性范围为０４～１６ｍｇ·ｍＬ－１，日内ＲＳＤ为０３５％，日间ＲＳＤ为０２７％～０４６％。结论：本法简便，快速，准确可靠。

Objective: A HPLC method for determination of tazobactam and its preparation piperacillin sodium and tazobactam sodium for injection was developed. Methods: The HPLC method for determination of tazobactam was:C18 column,mobile phase:pH 40 acetonitrile-005 molL-1 potassium dihydrogen phosphate-25 m molL-1 tetrabutylammonium hydroxide (18080515),detector wavelength:230 nm,flow rate:1 mLmin-1;the HPLC method for determination of piperacillin sodium and tazobactam sodium for injection was:C18 column,mobile phase:pH 35 methanolH2O-25 m molL-1 tetrabutylammonium hydroxide (45053515),detector wavelength:230 nm,flow rate:1 mLmin-1. Results: The linear range is 0132 mgmL-1,RSD within day is 03%,RSD between days is 042%065%;about the HPLC method for determination of tazobactam and both the linear ranges of piperacillin and tazobactam are 0416 mgmL-1 and 00510 mgmL-1,RSD of tazobactam within day is 11%,and RSD of tazobactam between days is 11%15%;RSD of piperacillin within day is 035%,and RSD of piperacillin be