摘要
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 an HPLC method for determination of the content and related substances of sul- bactam sodium by non-ionic chromatography system. Methods：C18 column was used, the mobile phase consisted of 5.44 g · L^-1 potassium dihydrogen phosphate solution （pH 4. 0） and acetonitrile. Degrees was used for determination of the content and gradient elution for related substances at a flow rate of 1 mL · min^-1, the detection wavelength was 215 nm. The column temperature was 30 ℃. Results：The calibration curve was linear within the range of 0. 022 -7. 451 mg· mL^- 1 （r = 0. 9999）. The mean recovery was 100. 4%, the detection limit and quantitative limit is 6. 7 ng and 22. 4ng, the detection limit of related substances is 2. 8 ng, the chromatographic peaks of sulbactam and its related substances were separated completely. Conclusin：Non -ionic chromatography system is of non -injury to the column, the method is simple and accurate and can be used for determination of sulbactam content and related substances.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第11期1797-1800,共4页
Chinese Journal of Pharmaceutical Analysis
