CAJ | 학술논문

目的：建立注射用哌拉西林钠舒巴坦钠有关物质测定方法。方法采用C18柱；流动相为：水、乙腈、0.2mol/L磷酸二氢钾溶液，线性梯度洗脱；检测波长为220nm。结果线性范围为舒巴坦1.5～36.3μg/mL，1-乙基哌嗪-2，3-二酮1.7～40.6μg/mL，氨苄西林1.4～34.5μg/mL，哌拉西林1.6～38.2μg/mL；重复性为1-乙基哌嗪-2，3-二酮RSD 4.8%，氨苄西林RSD 14.1%，杂质ⅡRSD 4.1%；1-乙基哌嗪-2，3-二酮的回收率均值为（98.9±7.8）%，氨苄西林回收率均值为（103.8±9.7）%；哌拉西林的定量限为4ng，检测限为1ng。样品溶液不稳定，需要配制后立即进样，耐用性试验显示需要选定专用色谱柱。结论本方法简便，专属性、重复性良好，可用于注射用哌拉西林钠舒巴坦钠有关物质的测定。
목적：건립주사용고랍서림납서파탄납유관물질측정방법。방법채용C18주；류동상위：수、을정、0.2mol/L린산이경갑용액，선성제도세탈；검측파장위220nm。결과선성범위위서파탄1.5～36.3μg/mL，1-을기고진-2，3-이동1.7～40.6μg/mL，안변서림1.4～34.5μg/mL，고랍서림1.6～38.2μg/mL；중복성위1-을기고진-2，3-이동RSD 4.8%，안변서림RSD 14.1%，잡질ⅡRSD 4.1%；1-을기고진-2，3-이동적회수솔균치위（98.9±7.8）%，안변서림회수솔균치위（103.8±9.7）%；고랍서림적정량한위4ng，검측한위1ng。양품용액불은정，수요배제후립즉진양，내용성시험현시수요선정전용색보주。결론본방법간편，전속성、중복성량호，가용우주사용고랍서림납서파탄납유관물질적측정。
Objective To establish a method for the determination of related substances of piperacillin sodium and sulbactam sodium for injection.MethodsThe C18 column was used; The moving phase included water, acetonitrile and 0.2mol/L monopotassium solution, and the linear gradient elution was used; The detection wavelength was 220nm. ResultsThe linear range was 1.5-36.3μg/mL for sulbactam, 1.7-40.6μg/mL for 1-ethyl-piperazine-2, 3-dione, 1.4-34.5μg/mL for ampicillin, 1.6-38.2μg/mL for piperacillin respectively; The repeatability was RSD 4.8% for 1-ethyl-piperazine-2, 3-dione, RSD 14.1% for ampicillin and RSD 4.1% for impurity II respectively; The recovery rate was (98.9±7.8)% for 1-ethyl-piperazine-2, 3-dione and (103.8±9.7)% for ampicillin respectively; The quantitative limit of piperacillin was 4ng and the detection limit was 1ng. The sample solution was unstable and needed immediate sample introduction after preparation. Durability tests showed the need for dedicated chromatographic column.ConclusionThis method is simple and convenient and has good specificity and repeatability, thus can be used for the determination of related substances of piperacillin sodium and sulbactam sodium for injection.