TSK凝胶色谱系统测定注射用盐酸头孢替安有关物质Ⅱ  

Determination of Related SubstancesⅡin Cefotiam Hydrochloride for Injection by TSK Gel Chromatographic System

作　　者：王娜 李园园 闫乐乐 WANG Na;LI Yuan-yuan;YAN Le-le(Shandong Lukang Pharmaceutical Co.,Ltd.,Jining 272100,China)

机构地区：[1]山东鲁抗医药股份有限公司,山东济宁272100

出　　处：《食品与药品》2020年第3期183-187,共5页Food and Drug

摘　　要：目的 建立测定注射用盐酸头孢替安中的有关物质Ⅱ的高效液相凝胶色谱法.方法 采用TSK GEL 2000SWXL色谱柱(TOSOH,7.8 mm×300 mm,5μm),以pH 7.0的0.005 mol/L磷酸盐缓冲液[磷酸氢二钠溶液-磷酸二氢钠溶液(50:50)]-乙腈=90:10为流动相,检测波长为254 nm,流速为0.6 ml/min.结果 头孢替安对照品溶液在0.19-19.05μg/ml范围内,溶液浓度和峰面积呈良好的线性关系(r=0.9999).重复性试验RSD为1.42%(n=6),中间精密度试验RSD为1.60%(n=12).结论 该凝胶色谱方法操作简便,专属性强,灵敏度高,结果可靠,适用于注射用盐酸头孢替安中有关物质Ⅱ的检测.Objective To establish a high performance gel chromatography for determination of the related substancesⅡin Cefotiam Hydrochloride for Injection.Methods The analytical column was TSK GEL 2000 SWXL(TOSOH,7.8 mm×300 mm,5μm).The mobile phase consisted of phosphate buffer(pH 7.0)[0.005 mol/L disodium hydrogen phosphate and 0.005 mol/L sodium dihydrogen phosphate(50:50)]and acetonitrile(90:10).The detective wavelength was 254 nm,and the flow rate was 0.6 ml/min.Results There was good linearity between the concentration of cefotiam reference solution and the peak area in the range of 0.19-19.05μg/ml(r=0.9999).RSD of repeatability test was 1.42%(n=6),and RSD of intermediate precision test was 1.60%(n=12).Conclusion The method is simple,specific,sensitive and reliable,and is suitable for the determination of the related substancesⅡin Cefotiam Hydrochloride for Injection.

关 键 词：TSK凝胶色谱系统 注射用盐酸头孢替安 有关物质Ⅱ 

分 类 号：R917[医药卫生—药物分析学]