HPLC法在合成盐酸甲基麻黄碱检测相关物质的应用  

作　　者：李树学 李德林 李志杰 马岩 

机构地区：[1]赤峰艾克制药科技股份有限公司,赤峰024001

出　　处：《北方药学》2014年第5期10-11,共2页Journal of North Pharmacy

摘　　要：目的：采用高效液相色谱法代替国家标准中TLC检测合成盐酸甲基麻黄碱相关物质，完善合成盐酸甲基麻黄碱质量标准。方法：以苯基键合硅胶为固定相（Alhima色谱柱250mm×4．6mm），以0．15M醋酸盐缓冲液：甲醇（94：6）用冰乙酸调节pH值至4．0。检测波长257nm，流速1．0ml/ml。结果：专属性，样品与对照品分离度〉2．0；系统适用性，峰面积变化的RSD为1．1％；在10．13～81．04μg/ml范围内，线性关系良好（1=0．9999）；重现性RSD为1．26％、耐用性符合要求、准确度RSD为1．31％；HPLC法检测限为：0．004％；TLC法检测限为0．25％。结论：方法快速、简便，重现性好，灵敏度高，可用于盐酸甲基麻黄碱相关物质检测。Objective： To detect synthetic ephedrine hydrochloride meth-related sμbstances by HPLC instead of thin-layer chromatography.To improved synthetic ephedrine hydrochloride methyl qμality standards.Methods： phenyl bonded silica gel as the stationary phase（Alhima colμmn 250mm×4.6mm）,0.15M acetate bpμffer： methanol（94：6） to adjμst the pH to 4.0 with glacial acetic acid as the mobile phase.Detection wavelength was 257nm, flow rate was 1.0ml/ml. Resμlts： The separation between sample and reference was 2.0. system sμitability peak area RSD was 1.1%. linear relationship （r=0.9999）. reprodpμcibility RSD was 1.26%. Dμrability meet the reqμirements. The detection limit of HPLC was 0.004%.TLC detection limit was 0.25%..Conclμsion： The method is rapid, simple,stable,and can be p, sed for methyl ephedrine hydrochloride related sμbstances testing.

关 键 词：高效液相色谱法 合成 盐酸甲基麻黄碱 相关物质 

分 类 号：R927.2[医药卫生—药学]