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目的 :建立测定注射用头孢噻肟钠他唑巴坦钠含量的方法。方法 :采用HPLC法 ,色谱柱为ODS柱 ,流动相为乙腈磷酸二氢钾溶液 (0 .0 3mol/L) - 10 %氢氧化四丁基铵 (190∶795∶15 ) ,并用磷酸调节pH为 4 .0 ,检测波长为 2 30nm。结果 :精密度及稳定性均良好 ;头孢噻肟及他唑巴坦浓度分别在 99.4～ 895 μg和 2 0 .6～185 μg范围内 ,峰面积与浓度呈良好的线性关系 ,相关系数为 0 .9998和 0 .9999,平均回收率为 10 0 .2 %和10 0 .1% ,RSD分别为 0 .95 %和 1.2 % ;他唑巴坦和头孢噻肟之间的分离度为 7,与其他杂质峰的分离度符合要求。结论 :该方法简便、专属、重现性好 ,可同时测定他唑巴坦钠和头孢噻肟钠的含量。
Objective: To establish a method for determination of cefotaxime sodium and tazobactam sodium for injection. Methods: The HPLC method was adopted. The column was ODS column. The mobile phase consisted of acetonitrile and potassium dihydrogen phosphate solution (0.03mol / L) and 10% tetrabutylammonium hydroxide (190:795:15) Is 4.0, the detection wavelength is 230nm. Results: The precision and stability were good. The concentrations of cefotaxime and tazobactam were 99.4 ~ 895 μg and 20.6 ~ 185 μg, respectively. There was a good linear relationship between the peak area and concentration, and the correlation coefficient was 0 .9998 and 0.9999, the average recovery was 100.2% and 100.1% with RSDs of 0.95% and 1.2%, respectively; the separation between tazobactam and cefotaxime was 7, The resolution of other impurity peaks meets the requirements. Conclusion: The method is simple, specific, reproducible, and can be used to determine the content of tazobactam sodium and cefotaxime sodium simultaneously.