高效液相色谱法测定头孢匹罗中2,3-环戊烯并吡啶及有关物质  

Determination of the Specified Impurity 2,3-Cyclopentenopyridine and Related Substances in Cefpirome Sulfate with HPLC

作　　者：王琼芬 陈悦[2] 

机构地区：[1]浙江省舟山市药品检验所,定海316000 [2]浙江省药品检验所,杭州310004

出　　处：《医药导报》2005年第12期1157-1159,共3页Herald of Medicine

摘　　要：目的采用高效液相色谱法测定头孢匹罗中的特定杂质2,3-环戊烯并吡啶及其他杂质.方法用十八烷基硅烷键合硅胶为色谱柱,用0.02mol·L-1磷酸二氢钠水溶液-乙腈(90:10)(用氢氧化钠试液调节pH值至5.6±0.05)为流动相;流速1.5 mL·min-1;柱温35℃;检测波长265 nm.结果2,3-环戊烯并吡啶峰及其他降解产物峰与头孢匹罗峰有良好的分离;2,3-环戊烯并吡啶在0.25～20.00μg·mL-1浓度范围内质量与峰面积呈良好的线性关系;供试品含有关物质含量为0.05%～5%时,质量与峰面积呈良好的线性关系.结论该方法简便高效,灵敏度高,专属性强,可用于头孢匹罗的杂质控制和药物稳定性实验研究.Objective cefpirome sulfate with HPLC To determine the specified impurity 2, 3-cyclopentenopyridine and related substances in Methods A SHIMADZU Shim-pack VP-ODS （4. 6 mm × 150 mm, 5μm） served as the chromatographic column. The mobile phase was 0.02 mol · L^-1 sodium dihydrogen phosphate solution-acetonitrile （90 ： 10）, the pH being adjusted to （5.6 ± 0.05） with sodium hydroxide. The flow rate was 1.5 mL · min^-1 , the column temperature , 350170, and the detection wavelength was 265 nm. Results The peaks of 2,3-cyclopentenopyridine and other degradation products were well separated from those of cefpirome. The calibration curves were linear when the concentrations of 2, 3- cyclopentenopyridine and related substances were in the range of 0.25 - 20.00 μg · mL^-1 and 0.05% ～ 5% , respectively. Conclusion The method was shown to be handy, efficient, sensitive and exclusive. It can thus be used for the impurity control and experimental studv of the drug stability of cefpirome sulfate.

关 键 词：头孢匹罗 2 3-环戊烯并吡啶 高效液相色谱法 

分 类 号：R978.11[医药卫生—药品] R927.2[医药卫生—药学]