高效液相色谱法测定注射用头孢噻肟钠舒巴坦钠中2-巯基苯并噻唑的残留量  

Determination of 2-Mercaptobenzothiazole as Potential Genotoxic Impurities in Cefotaxime Sodium and Sulbactam Sodium for Injection by High Performance Liquid Chromatography Method

作　　者：徐家根[1] 顾琦欣 傅辰超 XU Jiagen;GU Qixin;FU Chenchao(Department of Pharmacy,Nanjing Stomatological Hospital,Medical School of Nanjing University,Nanjing 210008,China;Nanjing Yoko Pharmaceutical Co.,Ltd.,Nanjing 210009,China)

机构地区：[1]南京大学医学院附属口腔医院,南京市口腔医院药学部,南京210008 [2]南京优科制药有限公司,南京210009

出　　处：《药学与临床研究》2020年第6期435-437,共3页Pharmaceutical and Clinical Research

摘　　要：目的:建立高效液相色谱法测定注射用头孢噻肟钠舒巴坦钠中2-巯基苯并噻唑的残留量。方法:高效液相色谱法的色谱柱:用十八烷基硅烷键合硅胶为填充剂Kromasil 100-5-C18(250 mm×4.6 mm,5μm);流动相:甲醇^-10 mmol·L^-1乙酸铵(55∶45);柱温:30℃;检测波长:320 nm;流速:1.0 mL·min^-1;进样量:10μL。结果:定量限、检测限、线性关系、耐用性、重复性、进样精密度均良好。结论:本法可用于注射用头孢噻肟钠舒巴坦钠中2-巯基苯并噻唑限度的测定。Objective:To establish an efficacious high performance liquid chromatographic method to measure the content of 2-mercaptobenzothiazole in Cefotaxime Sodium and Sulbactam Sodium for Injection.Methods:The high performance liquid chromatographic method was set as follows:Chromatography column,Kromasil 100-5-C18(250 mm×4.6 mm,5μm);Mobile phase,methanol-10 mmol·L^-1 ammonium acetate(55∶45);Column temperature,30℃;Detection wavelength,320 nm;Flow rate,1.0 mL·min^-1;Sample volume,10μL.Results:Quantitative limit,detection limit,stability of the solution,linear,durability,repeatability and sampling precision were all verified to be acceptable.Conclusion:The method can be used for the determination of the content of 2-mercaptobenzothiazole.

关 键 词：注射用头孢噻肟钠舒巴坦钠 高效液相色谱法 基因毒性杂质 

分 类 号：R927.11[医药卫生—药学]