摘要
目的:建立头孢丙烯中有关物质的检测方法。方法:采用高效液相色谱法,固定相为C18柱,流动相为乙腈-磷酸二氢铵溶液(10:90),检测波长为280nm。结果:头孢丙烯与各有关物质达到了较好的分离,顺式异构体和反式异构体峰的相对保留时间分别为0.7和1.0,分离度大于2.5。3批样品的中间体杂质含量分别为0.14%、0.15%和0.15%,其它最大单个杂质含量分别为0.38%、0.39%和0.36%,杂质总量分别为1.20%、1.15%和1.18%。结论:本法简便、专属性强、准确度高、重复性好,可用于测定头孢丙烯中的有关物质。
Objective： To establish a suitable method for the determination of related substances in cefprozil by RP-HPLC. Methods： The C18 column（250 mm × 4.6 mm, 5 μm） and the acetonitrile-phos- phate buffers solution （ 10： 90） were used, and the detection wavelength was at 280 nm. Results： The resolution between cefprozil and the related substances was ideal. Three batches of samples were tested and the content of the known related substances was 0.14%, 0.15% and 0.15%, respectively. The content of the other maximum individual impurity was 0.38%, 0.39% and 0.36%, respectively and the total con- tent was 1.20%, 1.15% and 1.18%, respectively. Conclusion： This method is simple and accurate. It may be used to determine the related substances in cefprozil.
出处
《药学进展》
CAS
2009年第1期34-37,共4页
Progress in Pharmaceutical Sciences
