Qualitative and quantitative assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream by HPLC-TOF-MS and HPLC

作     者：Wenling Yang Xiaomei Yang Fanghua Shi Zhigang Liao Yongkun Liang Liangzhong Yu Ruixun Wang Qing Li Kaishun Bi 

作者机构：School of Pharmacy Shenyang Pharmaceutical University Shenyang 110016 China G.D China Resources Shunfeng Pharmaceutical Co. Ltd Guangdong 528300 China 

出 版 物：《Journal of Pharmaceutical Analysis》 (药物分析学报（英文版）)

年 卷 期：2019年第9卷第3期

页      面：156-162页

核心收录：

学科分类：0710[理学-生物学] 1007[医学-药学(可授医学、理学学位)] 1002[医学-临床医学] 0817[工学-化学工程与技术] 0703[理学-化学] 0702[理学-物理学] 10[医学] 

主　　题：Compound Ketoconazole and Clobetasol Propionate Cream Ketoconazole impurity B' optical isomer Ketoconazole impurity E Quality control HPLC-TOF-MS HPLC 

摘      要：Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream. In this work, a reliable HPLC-TOF-MS qualitative method was developed for the analysis of related substances in this preparation with a quick and easy extraction procedure. Besides the active pharmaceutical ingredients, two compounds named ketoconazole impurity B′ optical isomer and ketoconazole impurity E were identified. Furthermore, a new HPLC method for qualitative and quantitative assessment on related substances and degradation products, which were found in the stability test, was established and validated. The single standard to determine multi-components method was applied in the quantitative analysis, which was an effective way for reducing cost and improving accuracy. This study can provide a creative idea for routine analysis of quality control of the Compound Ketoconazole and Clobetasol Propionate Cream.