HPLC法测定创新药Y101片剂中3个光学异构体的含量  

HPLC determination of three optical isomers in Y101 tablets

作　　者：张芳[1,2] 杨志强[2] 王杏林[2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193

出　　处：《药物分析杂志》2013年第2期189-192,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家973课题-基于释药动力学的非晶态给药体系的评价方法研究(2012CB724002);国家生物医药国际创新园(天津)创新药物孵化基地建设(2010ZX09401)

摘　　要：目的:建立高效液相色谱法测定Y101片剂中3个光学异构体含量的方法。方法:采用DAICEL CHIRALPAK AD-H手性柱(250 mm×4.6 mm,5μm),流动相为正己烷-异丙醇-二乙胺(85∶15∶0.1),流速0.8 mL.min-1,柱温30℃,检测波长226 nm,进样量40μL。结果:Y101与3个光学异构体分离良好,Y101检测浓度的线性范围为0.1042～0.8336μg.mL-1(r=0.9999),检测限为2.9176 ng。结论:该方法操作简便,结果准确,可用于Y101片剂中3个光学异构体的含量测定并控制其异构体的限度。Objective：To establish an HPLC method for the determination of three optical isomers in Y101 tablets. Method ：The separation was performed on an DAICEL CHIRALPAK AD - H ehiral column （250 mm x 4. 6 mm, 5 txm）. The mobile phase was n -hexane -/so -propylaleohol -diethylamine（85： 15： 0. 1 ）at a flow rate of 0. 8 mL· min^-1. The column temperature was 30℃, and the detection wavelength was set at 226 nm. The injection volume was 40 μL. Results：Y101 and three optical isomers were well separated. The linear range of Y101 was 0. 1042 -0. 8336μg · mL^-1 （r =0. 9999） ,the detection limit was 2. 9176 ng. Conclusion：The method is proved to be simple and accu- rate ,which is suitable for the content determination and purity determination of three optical isomers in Y101 tablets.

关 键 词：高效液相色谱法 手性柱 N-[N-苯甲酰基-O-(2-二乙氨基乙基)-L-酪氨酰基]-L-苯丙氨醇 Y101 光学异构体含量测定 创新药质量控制 

分 类 号：R917[医药卫生—药物分析学]