摘要
目的:建立测定头孢氨苄原料药中聚合物含量的方法。方法:采用高效分子排阻色谱法。色谱柱为TSK-GELG2000SWXL,流动相为0.005mol/L磷酸盐缓冲液[0.005mol/LNaH2PO4溶液-0.005mol/LNa2HPO4溶液(39:61,V/V)]-乙腈(95:5,V/V),流速为0.6ml/min,检测波长为220nm,进样量为20μl。结果:头孢氨苄检测质量浓度线性范围为0.56～28.0μg/m(lr=0.9999),分析时间约为20min,重复性较好(RSD=2.4%,n=6),以头孢氨苄计检出限为1.0ng、定量限为3.0ng。结论:本方法分离效能高、检验周期短、准确可靠。
OBJECTIVE： To establish a method for the content determination of polymers in cefalexin. METHODS： HPSEC method was adopted. A TSK-GEL G2000SWxL column was used with mobile phase consisted of 0.005 mol/L phosphate buffer solu- tion [0.005 mol/L NaH2PO4 solution-0.005 mol/L Na2HPO4 solution（39：61, V/V）]-acetonitrile （95：5, V/V） at the flow rate of 0.6 ml/ min. The detection wavelength was set at 220 nm and injection volume was 20 μl. RESULTS： The linear range of cefalexin was 0.56-28.0 μg/ml （r=0.999 9）. The analytic time was 20 min, and good repeatability was obtained （RSD=2.4%, n=6）. The limit of detection was 1.0 ng and the limit of quantitition was 3.0 ng. CONCLUSIONS： The specific method is efficient, short in dura- tion and with accurate and reliable result.
出处
《中国药房》
CAS
CSCD
2013年第5期463-464,共2页
China Pharmacy
