高效分子排阻色谱法分析注射用头孢噻吩钠中的高分子杂质.pdfVIP

2010 11 5 340 D rug Standards o f China 2010, V ol11 N o5 [ J] 2007, 25 ( 6 : 388390 [ J] 2002, 14( 5 : 6667 [ 7 ] [ 9] , , H PLC [ J] 2007, 22 ( 2 : 5556 [ J] 2007 , 18 ( 19 : [ 8] R PHPLC 王成刚, 周立春, 王俊秋( , 100035 : 建立高效分子排阻色谱( HPSE C 法测定注射用头孢噻吩钠中的高分子杂 : 采用 T SKGEL G2000SWX L 凝 胶色谱柱 ( 30 cm 78 mm 5 m , 流动相为 0002 m o l L- 1磷酸盐缓冲液( pH 70 乙腈 ( 95!5 , 流速为 06 mL m in- 1, 检测波长 235 nm: 头孢噻吩和高分子杂 的线性范围分别为 101~ 257 g mL- 1 ( r = 1000 和 00252 ~ 700 g L- 1 ( r = 1000 ; 头孢噻吩的检测限为 05 ng, 头孢噻吩高分子杂 的定量限以头孢噻吩计为 14 ng; 对照溶液重复进样( n = 6 的精密度( RSD 为 023% , 样品测定( n = 6 的重复性( R SD 为 070% : 本方法操作简单, 专属性强, 灵敏度高 : 头孢噻吩; 高分子杂 ; H PSEC : R 927 : A : 1009- 3656( 2010 - 5- 340 - 3 Determ ination of H igh M olecularW eight Im purities in Cefalitin Sodium for Injection by HPSEC W ang Chenggang, Zhou L ichun, W ang Junqiu(B eij ing In sti tu tef or D rug C on tro,l B eij ing 100035) Abstract Objecti e: T o estab lish a h igh per fo rm ance size exc lu sion chroma tog raphy ( HPSE C m ethod for the determ ination o f high m olecular w e ight mi purities in C efa lo tin Sodium for In jectionM ethods: A T SKG EL G2000SW X L co lum n ( 30 cm 78 mm 5 m w as u sed w ith the mob ile phase consisted of 0002 mo l L- 1 phosphate bu ffer so lution ( pH 70 ace ton itrile ( 95: 5 at a flow rate - 1 o f 06 mL m in , and the detec tion w avelength w as at 235 nm Results: The ca libra tion curves w ere linear in the range of 101~ 257 g mL - 1 for Cefa lotin ( r= 1000 and 0025 2~ 700 g L- 1 fo r h igh mo lecu la r w eight mi pur ities ( r = 1000 The lmi it of