摘要
目的:用 HPLC 法测定注射用头孢尼西钠的含量及其有关物质。方法:采用 Kromasil C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-水-0.2 mol·mL^(-1)磷酸二氢铵(21:74:5)为流动相,流速1.0 mL·min^(-1),检测波长为254 nm;柱温:40℃。结果:头孢尼西钠与其相邻杂质峰能完全分离,头孢尼西钠在22～132μg·mL^(-1)浓度范围内线性关系良好(r=0.9999)。结论:该法简便、准确、专属性好,可以用于注射用头孢尼西钠的含量测定及有关物质检查。
Objective：To establish an HPLC method for the determination of cefonicid sodium and its related substances for injection. Methods：The column：adoptod was Kromasil C lS column （250mm×4.6mm,5μm） with mobile phase a acetonitrile -water- 0.2 mol·mL^-1 ammonium dihydrogen phosphate （21：74：5） at flow rate of 1.0 mL·min^-1. The detection wavelength was and 254 nm column temperature at 40 ℃. Results： Cefonicid sodium could be completely separated from the other impurities. The linear range of cefonicid sodium was 22 - 132μg·mL^- 1 （ r = 0. 9999 ）. Conclusion： The method is simple, accurate and is suitable for the determination of cefonicid sodium and its related substances in its injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第8期1256-1260,共5页
Chinese Journal of Pharmaceutical Analysis
