HPLC法测定腹膜透析液中头孢呋辛钠的含量及其配伍稳定性考察

目的:建立腹膜透析液中头孢呋辛钠的含量测定方法并考察二者配伍稳定性。方法:采用高效液相色谱法测定头孢呋辛钠含量,色谱柱为Phenomenex Luna C18,流动相为乙腈-0.05mol·L-1醋酸钠缓冲液(pH3.9)=10∶90,流速为1.0mL·min-1,检测波长为273nm;考察头孢呋辛钠水溶液、头孢呋辛钠腹膜透析液放置6h后的不溶性微粒、澄清度、外观性状、pH值及含量。结果:头孢呋辛钠检测浓度线性范围为1.25～125μg·mL-1(r=0.9998),平均回收率为99.6%,RSD为0.6%(n=6);2种溶液6h内各检查指标均无明显变化。结论:所建立的含量测定方法简单、准确、灵敏,可用于腹膜透析液中头孢呋辛钠的含量测定;头孢呋辛钠与腹膜透析液配伍6h内稳定性良好。

Content Determination of Cefuroxime in Peritoneal Dialysis Solution by HPLC and Compatible Stability of the Mixture

OBJECTIVE：To establish the method for the content determination of cefuroxime in Peritoneal dialysis solution,and to investigate the compatible stability of the mixture.METHODS：HPLC method was adopted to determine the content of cefuroxime.The column was Phenomenex Luna C18 with mobile phase consisted of acetonitrile-0.05 mol·L-1 NaAc buffer（pH=3.9）（10：90） at the flow rate of 1.0 mL·min-1.The detection wavelength was 273 nm.Cefuroxime solution and Cefuroxime peritoneal dialysis solution were investigated after setting 6 h in terms of insoluble particles,clarity,appearance,property,pH value and content.RESULTS：The linear range of cefuroxime was 1.25～125 μg·mL-1（r=0.999 8） with an average recovery of 99.6%（RSD=0.6%,n=6）.No significant change was found in each index of 2 kinds of solution within 6 h.CONCLUSION：Established method is simple,accurate and sensitive.And it is suitable for the content determination of cefuroxime in Peritoneal dialysis solution.Cefuroxime and Peritoneal dialysis solution are compatible within 6 h.