高效液相色谱法测定注射用头孢曲松钠三唑巴坦钠的含量

 目的建立高效液相色谱法测定注射用头孢曲松钠三唑巴坦钠含量方法。方法色谱柱:Diamonsil^TM(钻石)C₁₈(4.6 mm ×250 mm,5 μm);柱温:30℃;流动相:乙腈-磷酸二氢钾溶液(0.03 mol·L^-1)-10%四丁基氢氧化铵溶液(300:685:15)(用磷酸调pH值为4.0);流速:1.0 mL·min^-1);检测波长:220 nm;进样量20μL。结果头孢曲松的线性范围为0.045～3.6 g·L^-1,r= 0.9997,日内RSD为0.2%,日间RSD为0.2%～0.6%,平均回收率为99.6%;三唑巴坦的线性范围在0.75～450 mg·L^-1,r= 0.9999,日内RSD为0.3%,日间RSD为0.3%～1.1%,平均回收率为99.2%(n=6)。结论本方法简便快速,选择性好,精密度高,准确可靠,可作为控制注射用头孢曲松钠三唑巴坦钠质量的方法。

Determination of ceftriaxone sodium/tazobactam sodium for injection by HPLC

OBJECTIVE To develop a high performance liquid chromatography method for determinating content of ceftriaxone sodium/tazobactam sodium for injection. METHODS The analytical column was Diamonsil^TM C₁₈ (4.6mm×250mm, 5μm). The mobile phase was a mixture of acetonitrile-0.03 mol·L^-1 monobasie potassium phosphate-10% tetrabutylammonium hydroxide(300: 685: 15), adjusted with phosphoric acid to a pH of 4.0. The flow rate was 1.0 mL·min^-1, the detection wavelength was 220 um and the injection volume was 20μL. RESULTS The caliblation curve for ceftriaxone was linear in the range of 0.045 to 3.6 g·L^-1, r=0.9997. The precision was 0.2%, the repeatability was 0.2% to 0.6% and the average recovery was 99.6%. The caliblation curve for tazohactam was linear in the range of 0.75 to 600 mg·L^-1,r=0.9999. The precision was 0.3%, the repeatability was 0.3% to 1.1% and the average recovery was 99.2%. CONCLUSION The method is convenient, selective, accurate and reproducible for the assay of ceftriaxone sodium/tazobactam sodium for injection.