Solriamfetol impurities:Synthesis,characterization,and analytical method(UPLC-UV)validation
作者机构：Pharmaceutical and Chemical Engineering DepartmentSchool of Medical SciencesGerman Jordanian UniversityAmmanJordan Faculty of PharmacyZarqa UniversityZarqaJordan Research and Development DepartmentResonance Research LabAmmanJordan Department of PharmaceuticsCollege of PharmacyKing Khalid UniversityAbhaSaudi Arabia
出 版 物：《Journal of Pharmaceutical Analysis》 (药物分析学报（英文版）)
年 卷 期：2023年第13卷第4期
页 面：403-411页
核心收录：
学科分类：1007[医学-药学(可授医学、理学学位)] 100704[医学-药物分析学] 10[医学]
主 题：Solriamfetol Impurity analysis Impurity synthesis UPLC Method validation
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 *** 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 *** 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 ***,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 ***,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.
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