HPLC法同时测定头孢哌酮钠舒巴坦钠注射剂中头孢哌酮钠和舒巴坦钠含量
刘守琼 1汪健 1姚迅 1邓斌1
作者信息
- 1. 重庆市食品药品检验检测研究院重庆 401120
- 折叠
摘要
目的:,建立同时测定头孢哌酮舒巴坦注射液中头孢哌酮和舒巴坦含量的HPLC法。方法:采用SymmetryshieldTMRP18(5um,4.6×250mm)色谱柱,流动相为0.005mol/l四丁基氢氧化铵溶液(取10%四丁基氢氧化铵溶液26.4ml,加水800ml后,用1mol/l磷酸溶液调节pH值至4.0,再用水稀释至2000ml,摇匀):乙腈(750:250),检测波长为220nm。结果:头孢哌酮和舒巴坦的线性范围分别为:0.279~4.462mg/m1(r=0.9999)和0.120~1.926mg/m1(r=0.9998);平均回收率(n=9)分别为100.73%(RSD=0.38%)和101.11%(RSD=0.36%)。结论:该方法精密度好、准确可靠,可用于该制剂的质量控制。
Abstract
Objective: To establish an HPLC method for simultaneous determination of Cefoperazone Sodium and Sulbactam Sodium in the Cefoperazone Sodium and Sulbactam Sodium injection.Methods: SymmetryshieldTMRP18(5um, 4.6×250mm)column was adopted with a mobile phase of 0.005mol/l tetrabutyl ammonium hydroxide solution(26.4ml of 0.005mol/l tetrabutyl ammonium hydroxide was added to 800ml of water, adjusted with 1mol/l H3PO4 to pH 4.0, then diluted with water to 2000ml ): Acetonitrile (750:250). The UV detection was set at 220nm. Result: The linear ranges of Cefoperazone Sodium and Sulbactam Sodium were 0.279~4.462mg/m1(r=0. 9999)and 0.120~1.926mg/m1(r=0.9998), respectively; The average recoveries(n=9) were 100.73%(RSD=0.38%)and 101.11%(RSD=0.36%). Conclusion: This method is accurate and reliable, so it can be used for quality control of this preparation.
关键词
HPLC/头孢哌酮/舒巴坦/含量测定Key words
HPLC/Cefoperazone Sodium/Sulbactam Sodium/assay引用本文复制引用
出版年
2015