HPLC法测定D-色氨酸甲酯盐酸盐中的左旋异构体  

Determination of L-isomer in D-tryptophan Methyl Ester Hydrochloride by HPLC

作　　者：夏星雅 韩承刚 郑枫[1,2,3] XIA Xing-ya;HAN Cheng-gang;ZHENG Feng(Department of Pharmaceutical Analysis,China Pharmaceutical University,Jiangsu Nanjing 210009;Key Laboratory of Drug Quality Control and Pharmacovigilance,Ministry of Education,China Pharmaceutical University,Jiangsu Nanjing 210009;Zhejiang Center for Safety Study of Drug Substances(Industrial Technology Innovation Platform),Jiangsu Hangzhou 310018,China)

机构地区：[1]中国药科大学药物分析教研室,江苏南京210009 [2]药物质量与安全预警教育部重点实验室,江苏南京210009 [3]浙江省原料药安全研究中心(工艺技术创新平台),浙江杭州310018

出　　处：《广州化工》2022年第7期112-115,共4页GuangZhou Chemical Industry

摘　　要：建立了测定D-色氨酸甲酯盐酸盐中左旋异构体的手性高效液相色谱方法。采用EnantioPak Y5(4.6 mm×250 mm, 5μm)色谱柱,以正己烷(含0.1%二乙胺)-乙醇(80:20)为流动相,检测波长280 nm。D-色氨酸甲酯盐酸盐与其左旋异构体之间分离度良好,L-色氨酸甲酯盐酸盐在0.9927~14.8905μg·mL^(-1)浓度范围内线性关系良好;D-色氨酸甲酯盐酸盐在0.9839~14.7588μg·mL^(-1)浓度范围内线性关系良好,R^(2)均为0.9998。本方法准确、简便,可以用于D-色氨酸甲酯盐酸盐中左旋异构体的质量研究。A chiral HPLC method for the determination of L-isomer in D-tryptophan methyl ester hydrochloride was established. The determination was performed on a EnantioPak Y5 column(4.6 mm×250 mm, 5 μm),and the mobile phase consisted of n-hexane(containing 0.1% diethylamine)-ethanol(80:20). The detection wavelength was 280 nm. An excellent separation was achieved for D-tryptophan methyl ester hydrochloride and its L-isomer. The linear range of L-tryptophan methyl ester hydrochloride was 0.9927~14.8905 μg·mL^(-1)(R;=0.9998) and the linear range of D-tryptophan methyl ester hydrochloride was 0.9839~14.7588 μg·mL^(-1)(R^(2)=0.9998). The method is accurate, simple and reliable for the determination of L-isomer in D-tryptophan methyl ester hydrochloride.

关 键 词：D-色氨酸甲酯盐酸盐 异构体 高效液相色谱法 手性拆分 

分 类 号：R917[医药卫生—药物分析学]