摘要
目的对HPLC法测定头孢曲松钠和有关物质含量的方法进行改进。方法选用Thermo BDS HYPERSIL C18（250mm×4．6mm，5μm）色谱柱，流动相为甲醇．0．2％磷酸（30：70），检测波长为254nm；流速为1．0mL／min。结果本品中头孢曲松钠含量测定线性范围为4．580—6870ng（r=1．000），平均回收率为99．7％（RSD=0．5％，n=6）；检测限和定量限分别为0．09ng和0．31ng。结论该改进后的测定方法更快速、准确，重复性好；检测结果同《中国药典》（2010年版）的比较，基本一致。
Objective To improve the content determination method of Ceftriaxone sodium and its related substances by HPLC.Methods The Thermo BDS HYPERSIL C]8（250 mm×4.6 mm, 5 μm） column was used, and the mobile phase was composed of Methanol-0.2% Phosphoric acid solution （30：70）, the detection wavelength was 254 nm; and the flow was 1.0 mL/min. Results The method is suitable to determine the content of Ceftriaxone sodium and its related substances. The main peak and the other impurities peaks could be separated efficiently by this method. Ceftriaxone showed a good linearity in the range of 4.580-6 870 ng （r= 1.000） ; and the average recovery was 99.7% with RSD of 0. 5% （n = 6）, the LOD and LOQ were 0.09 ng and 0.31 ng. Conclusion This improvement method is more simple, more accurate and reproducible, and the determination result is the same as the described method in China Pharmacopoeia （2010）.
出处
《今日药学》
CAS
2014年第8期580-583,共4页
Pharmacy Today
关键词
头孢曲松钠
含量测定
有关物质
HPLC
改进
Ceftriaxone sodium
content determination
related substance
HPLC
improvement
