Solriamfetol impurities:Synthesis,characterization,and analytical method(UPLC-UV)validation  

作　　者：Nafisah Al-Rifai Anas Alshishani Fouad Darras Ola Taha Shereen Abu-Jalloud Lena Shaghlil Yousef Al-Ebini 

机构地区：[1]Pharmaceutical and Chemical Engineering Department,School of Medical Sciences,German Jordanian University,Amman,Jordan [2]Faculty of Pharmacy,Zarqa University,Zarqa,Jordan [3]Research and Development Department,Resonance Research Lab,Amman,Jordan [4]Department of Pharmaceutics,College of Pharmacy,King Khalid University,Abha,Saudi Arabia

出　　处：《Journal of Pharmaceutical Analysis》2023年第4期403-411,共9页药物分析学报（英文版）

基　　金：This research was funded by the Deanship of Scientific Research at the German-Jordanian University and the Deanship of Scientific Research at Zarqa University.The graphical abstract was created with BioRender software.

摘　　要：Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications such as solriamfetol,which is used to treat excessive daytime sleepiness.Although the highperformance liquid chromatography analysis of commercial solriamfetol has revealed the presence of several impurities,their synthesis,structure elucidation,and chromatographic determination have not been reported yet.To bridge this gap,we herein identified,synthesized,and isolated eight processrelated solriamfetol impurities,characterized them using spectroscopic and chromatographic techniques,and proposed plausible mechanisms of their formation.Moreover,we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection,revealing that its selectivity,linearity,accuracy,precision,and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Thus,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.

关 键 词：Solriamfetol Impurity analysis Impurity synthesis UPLC Method validation 

分 类 号：R917[医药卫生—药物分析学]