头孢氨苄的分析 2010版中国药典.pdf

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1、August 19,2010LCLCLCLC ApplicationApplicationApplicationApplication Lab,Lab,Lab,Lab,ShiseidoShiseidoShiseidoShiseido ChinaChinaChinaChinaNo.31,BDA International Business Park,2 Jing Yuan Street,BeijingEconomic Technological Development Zone,Beijing,China 100176Phone 010-6785-6801,FAX 010-6785-6882Se

2、parationSeparationSeparationSeparation ofofofof CefalexinCefalexinCefalexinCefalexinFig1Minutes246810121416182022242628mAU05001000150020002500300021536732 102575 0.023586 145935 2.4Fig2Minutes20.2520.5020.7521.0021.2521.5021.7522.0022.2522.5022.75mAU-20020406021536732 102575 0.023586 145935 2.4峰面积理论

3、塔板数分离度(左边相邻峰)Fig3Minutes024681012141618202224262830mAU0200400600800100012001400mAU0200400600800100012001400333520 0.0 24408465297 28.7 40587293455 39.0 993706865833 5.3 1289671176808 2.8 137101174614 2.2 94028头孢氨苄的分离头孢氨苄的分离separation ofcefalexin Column:CAPCELLPAK MGII 4.6 mm i.d.x 250 mm 5S；Mobile p

4、hase:A:0.2mol/Lphosphate buffer(at pH5.0,adjusted with Sodium hydroxide),B:methanol;B%(v/v)0min（2%）-1min（2%）-20min（30%）-23min（2%）-30min（2%）；,Oven temp.:30C,Detection:UV 220 nm,Sample 1.0mg/mL(L)in the mobilephase A，Injection volumne:20L.Sha WangOsamu ShirotaFig1 是对供试品的进样后的谱图，Fig2 是 Fig1 的局部放大谱图；Fig3 是适量的供试品在 80的水浴中加热60min 后试样的谱图。依照 2010 版药典对头孢氨苄中有关杂质的检测条件，对客户提供的原料药进行了供试品溶液的分析，结果如上图所示。主峰和相邻杂质间的分离度都符合要求。如有问题，请再联系我们。王莎城田修分离度理论塔板数峰面积