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目的:建立非离子对色谱系统高效液相色谱法测定舒巴坦钠的含量及有关物质。方法:采用C18色谱柱,以5.44 g.L-1磷酸二氢钾溶液(pH4.0)-乙腈为流动相,含量测定采用等度洗脱,有关物质采用梯度洗脱,流速1 mL.min-1,检测波长215nm,柱温30℃。结果:舒巴坦浓度在0.022～7.451 mg.mL-1范围内线性良好(r=0.9999),加样回收率平均为100.4%,含量检测限为6.7 ng、定量限为22.4 ng,有关物质检测限为2.8 ng,各杂质峰与主峰分离良好。结论:非离子对色谱系统对色谱柱无损伤,方法简单,结果准确,可用于测定舒巴坦钠的含量及有关物质。
OBJECTIVE: To establish a non-ion pair chromatography system for the determination of sulbactam sodium and its related substances by high performance liquid chromatography. Methods: C18 column with 5.44 gL-1 potassium dihydrogen phosphate solution (pH 4.0) - acetonitrile as the mobile phase, the determination of the content using an isocratic elution, the relevant substances gradient elution, the flow rate of 1 mL.min-1 , Detection wavelength 215nm, column temperature 30 ℃. RESULTS: The sulbactam concentrations were linear within the range of 0.022-7.451 mg.mL-1 (r = 0.9999). The average recovery was 100.4%, the limit of detection was 6.7 ng and the limit of quantification was 22.4 ng. The related substances The limit of 2.8 ng, the impurity peak and the main peak separation well. Conclusion: The non-ion pair chromatography system has no damage to the column, the method is simple and the results are accurate. It can be used to determine the content of sulbactam sodium and related substances.