Yaseen Saima Baig, Akram Arfa, Musharraf Syed Ghulam, Wajidi Mehwish, Tabassum Nargis, Nazir Nemat, Shah Syed Muhammad Zaki
Federal Urdu University of Arts Sciences and Technology, Karachi, Sindh Pakistan.
H.E.J Research Institute of Chemistry, International Center for chemical and Biological Sciences, University of Karachi, Karachi 75270, Pakistan.
MethodsX. 2022 May 23;9:101735. doi: 10.1016/j.mex.2022.101735. eCollection 2022.
The present research aims to propose a simple and accurate technique for the analysis of Rifaximin in the presence of its stress degradation products and analysis of degradation products by LC-MS/MS analysis. Rifaximin was submitted to forced degradation under the acid hydrolysis condition as prescribed by the ICH. The extract was prepared by firstly treated with HCl and heated about 4 to 8 h. The filtrate was collected and separated using dichloromethane followed by evaporation in rotary evaporator to obtain a solid crude extract which was then stored under refrigeration at -80 °C. Liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QTOF-MS/MS) was utilized to identify products in the drug sample. The data processing results revealed the presence of 9 products in the degraded sample of Rifaximin. This data article contains the [ + +] values, molecular formula, retention times and the comprehensive list of values detected during the LC- QTOF- MS/MS analysis.
本研究旨在提出一种简单准确的技术，用于在存在利福昔明的应力降解产物的情况下分析利福昔明，并通过液相色谱-串联质谱（LC-MS/MS）分析降解产物。按照国际人用药品注册技术协调会（ICH）规定的条件，将利福昔明进行酸水解强制降解。提取物的制备方法是首先用盐酸处理并加热约4至8小时。收集滤液，用二氯甲烷分离，然后在旋转蒸发仪中蒸发，得到固体粗提取物，然后在-80°C下冷藏保存。利用液相色谱四极杆飞行时间质谱（LC-QTOF-MS/MS）鉴定药物样品中的产物。数据处理结果显示，利福昔明降解样品中存在9种产物。本数据文章包含在LC-QTOF-MS/MS分析过程中检测到的[ + +]值、分子式、保留时间和 值的综合列表。
