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  

Determination of High Molecular Weight Impurities in Cefalitin Sodium for Injection by HPSEC

作　　者：王成刚[1] 周立春[1] 王俊秋[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药品标准》2010年第5期340-342,共3页Drug Standards of China

摘　　要：目的:建立高效分子排阻色谱(HPSEC)法测定注射用头孢噻吩钠中的高分子杂质。方法:采用TSK-GEL G2000SWXL凝胶色谱柱(30cm×7.8mm×5μm),流动相为0.002mol·L-1磷酸盐缓冲液(pH7.0)-乙腈(95∶5),流速为0.6mL·min-1,检测波长235nm。结果:头孢噻吩和高分子杂质的线性范围分别为1.01～25.7μg·mL-1(r=1.000)和0.0252～7.00g·L-1(r=1.000);头孢噻吩的检测限为0.5ng,头孢噻吩高分子杂质的定量限以头孢噻吩计为1.4ng;对照溶液重复进样(n=6)的精密度(RSD)为0.23%,样品测定(n=6)的重复性(RSD)为0.70%。结论:本方法操作简单,专属性强,灵敏度高。Objective：To establish a high performance size exclusion chromatography （HPSEC） method for the determination of high molecular weight impurities in Cefalotin Sodium for Injection. netbods：A TSK-GEL G2000SWXL column （30 cm ×7.8 mm ×5 μm） was used with the mobile phase consisted of 0. 002 mol · L^-1 phosphate buffer solution （pH 7.0） - acetonitrile （95：5 ） at a flow rate of 0. 6 mL ·min^ -1, and the detection wavelength was at 235 nm. Results ： The calibration curves were linear in the range of 1.01 - 25.7 μg · mL^-1 for Cefalotin （r = 1. 000） and 0. 025 2 -7.00 g ·L^-1 for high molecular weight impurities （r = 1. 000）. Tire limit of detection for cefalotin was 0. 5 ng, and the limit of quantitation for high molecular weight impurities calculated as cefalotin was 1.4 ng. The RSD for replicate injections of reference solution （n = 6） was 0. 23%, and the repeatability for 6 measurement results was 0. 70% Conclusion：The HPSEC method is simple, specific and sensitive.

关 键 词：头孢噻吩 高分子杂质 HPSEC 

分 类 号：R927[医药卫生—药学]