注射用头孢噻肟钠他唑巴坦钠（6∶1）含量测定方法的研究

摘要

Objective:To establish a new method for quantitative determination of cefotaxime and and tazobactam simultaneously in the injection preparation with cefotaxime sodium and tazobactam sodium at a ratio of 6 to 1.Methods: An RP-HPLC method was adopted.The analysis was performed on Agilent Eclipse Plus C18 column (4.6 mm ×250 mm, 5 μm) with a mobile phase consisting of methanol-potassium dihydrogen phosphate buffer (6.7 g potassium dihydrogen phosphate dissolved in water with 3ml of phosphoric acid and 2ml of butyl ammonium hydroxide and diluted to 1 000 ml) (27∶73) .The flow rate of of the mobil phase was 1.0 ml/min.The detection wavelength was set at 220nm;and column temperature was 30℃;Injection volume was 20ul.Re-sults:Cefotaxime and tazobactam were well-separated with resolution of 7.89.Cefotaxime and tazobactam was also separated from other impurities.The linear range of cefotaxime and tazobactam were 0.516~4.124μg and 0.083~0.663μg(r=1) respectively with RSD less than 1.04%;LOQs were 0.11 ng and 0.23 ng, respectively;The average recoveries of cefotaxime and tazobactam were 100.6%(RSD was 0.79%,n=9) and 100.4%( RSD was 0.94%, n=9),respectively.Conclusions: This method was proved to be simple, specific, accurate, and can be used to simultaneous determination of cefotaxime and tazobactam in cefotaxime sodium and tazobactam sodium (6∶1) for injection.%目的：建立同时测定注射用头孢噻肟钠他唑巴坦钠（6∶1）中头孢噻肟和他唑巴坦含量的方法。方法：采用反相高效液相色谱法。色谱柱为Agilent Eclipse Plus C18柱（250 mm ×4．6 mm，5μm），流动相为甲醇－磷酸二氢钾溶液（6．7 g磷酸二氢钾，3 ml磷酸，2 ml四丁基氢氧化铵，用水溶解并稀释至1000 ml）（27∶73），流速为1．0 ml／min，检测波长为220 nm，柱温为30℃，进样量为20μl。结果：头孢噻肟和他唑巴坦的进样量分别在0．516～4．124μg和0．083～0．663μg范围内和各自峰面积积分值呈良好线性关系（r＝1）；平均加样回收率分别为100．6％和100．4％，RSD分别为0．79％和0．94％（n＝9）。结论：该方法操作简便，专属性和耐用性好，结果准确，可同时测定注射用头孢噻肟钠他唑巴坦钠（6∶1）中头孢噻肟和他唑巴坦的含量。