注射用头孢哌酮钠舒巴坦钠的HPLC分析及其质量研究  

Quality study of cefoperazone sodium and sulbactam sodium for injection by HPLC

作　　者：张哲峰[1] 杨更亮[1] 梁贵键[2] 支丽娟[3] 陈义[4] 

机构地区：[1]河北大学,河北保定071002 [2]空军总医院,北京100036 [3]河北省儿童医院,河北石家庄050011 [4]中国科学院化学研究所,北京100080

出　　处：《中国药学杂志》2003年第6期462-464,共3页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金资助项目( 2 92 0 50 372 0 0 750 0 5);河北省自然科学基金( 2 0 2 0 96 );科技部资助项目 ( 2 0 0 2CCA310 0KJCX2 -H4 )

摘　　要：目的　建立头孢哌酮钠舒巴坦钠及其有关物质的HPLC分析方法 ,并考察溶媒结晶法和冷冻干燥法两种工艺产品的质量。方法　以三乙胺醋酸溶液 乙腈 1mol·L- 1 醋酸 水 (2 0∶1 4 0∶5∶835)为流动相 ,在ODS柱上同时测定头孢哌酮钠和舒巴坦钠 ,2 1 0nm检测。结果　两成分分离度及线性关系良好 ,回收率分别为 99.86 %和 1 0 0 .44% ,并可同时分离其中的头孢哌酮S异构体 ,T 1 551B及其它相关物质 ,冷冻干燥工艺产品的引湿性及有关物质含量高于溶媒结晶产品 ,在高温条件下前者质量下降速度高于后者。结论　分析方法准确 ,可靠 ;OBJECTIVE: To develop the method for the determination of cefoperazone sodium(CPZ) and sulbactam sodium(SBT) for injection and to measure the degradates of the products made by solvent crystallization and lyophilization method. METHOD: ODS column was used to assay cefoperazone and sulbactam simultaneously. Triethylamine glacial acetic acid solution-acetonitrile-1 mol&middotL-1 acetic acid-water(20:140:5:835) was used as the mobile phase, with UV detection at 210 nm. RESULTS: The components had good linear relation and their average recoveries were 99.86% for CPZ and 100.44% for SBT respectively. S isomer in CPZ,T-1551B and other related substances were seperated well. The quality character of CPZ made by solvent crystallization or lyophilization method was also studied. The latter was more hygroscopic than the former; and more degradation products were formed than the former at higher temperature. CONCLUSION: The determination method was accurate and reliable. The quality of the product made by solvent crystallization method is better than that of the product made by lyophilization method.

关 键 词：注射用头孢哌酮钠舒巴坦钠 HPLC分析 质量 研究 

分 类 号：R927[医药卫生—药学]