气相色谱法测定头孢吡肟中N-甲基吡咯烷杂质含量  

Determination of N-methlypyrrolidine in cefepime by GC

作　　者：何永佳[1] 刘学斌[1] 高晓芬[1] 曾慧[1] 

机构地区：[1]广州白云山制药股份有限公司,广州510515

出　　处：《中国抗生素杂志》2003年第9期524-525,共2页Chinese Journal of Antibiotics

摘　　要：目的　用顶空气相色谱法测定盐酸头孢吡肟中 N-甲基吡咯烷杂质含量。方法　顶空气相色谱法 ,采用 HP- 6 2 4毛细管柱 ,30 m× 0 .5 3mm;氢火焰检测器 ;柱温 :80℃ ;气化室温度 :2 5 0℃ ;检测器温度 :2 80℃ ;载气为氮气 ;内标物正丙醇。结果　 N-甲基吡咯烷浓度在 5× 10 - 5～ 2 .5× 10 - 4g时线性关系良好 ,线性方程为 A吡咯烷 / A内标 =9.17× 10 4 C+0 .5 78,相关系数为 r=0 .998;RSD(% ) =0 .76。平均回收率为 10 3% ;检测限为 1.2 2× 10 - 9g。结论　本方法简便、准确、适用性广 ,便于在生产过程中进行监控。A headspace GC method was described for determination of N-methlypyrrolidine in cefepime. The conditions were as follows: column: HP-624(30m×0.53mm), a FID detector, column temperature: 80℃, detection temperature: 280℃. The experimental results showed that r=0.998, relative standard deviations 0.76%, and the detection limits were 1.22×10 -9g . The method is effective, rapid and easy to control.

关 键 词：气相色谱法 头孢吡肟 N-甲基吡咯烷 含量测定 

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