注射用哌拉西林钠/他唑巴坦钠含量测定方法的研究

Studies on Assay of Piperacillin/Tazobactam for Injection

目的 :建立测定注射用哌拉西林钠 /他唑巴坦钠含量的方法。方法 :采用高效液相色谱法 ,色谱柱为Au toscienceKromasilC18柱 ,流动相为甲醇 - 0 2mol·L-1磷酸二氢钠 - 10 %氢氧化四丁基铵溶液 -水 (5 10∶5 0∶8∶432 ) ,并用 10 %磷酸溶液调节 pH为 5 5 ,检测波长为 2 30nm。 结果 :精密度及稳定性均良好 ;哌拉西林及他唑巴坦浓度分别在 0 2 44 0～ 1 46 37mg·mL-1和 0 0 317～ 0 190 3mg·mL-1范围内 ,峰面积与浓度 (mg·mL-1)呈良好的线性关系 ,相关系数均为 0 9999,平均回收率分别为 99 17%和 99 0 9% ,RSD分别为 0 43%和0 77% ;他唑巴坦和哌拉西林之间的分离度为 14,与其他杂质峰的分离度符合要求。结论 :本方法简便、专属、重现性好 ,可同时测定他唑巴坦钠和哌拉西林钠的含量。

Objective:To develop a method for assay of piperacillin sodium/tazobactam sodium for injection Methods:A RP-HPLC method was used with Autoscience Kromasil C 18 column 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 5 5,with the detection wavelength at 230 nm Results:Precision and stability were fine The linear correlation of piperacillin and tazobatam was observed from the concentrations of 0 244 0 to 1 463 7 mg·mL -1 ( r =0 999 9) and 0 031 7 to 0 190 3 mg·mL -1 ( r =0 999 9) The average recovery of piperacillin and tazobatam was (99 17±0 43)% and (99 09±0 77)% Resolution between tazobatam and piperacillin is 14,and the resolution between the respective peaks of tazobatam and piperacillin and the other peaks conform to the requirements Conclusion:The method was convenient,selective and reproducible for assay of tazobatam and piperacillin simultaneously