Dispersive Liquid-liquid Microextraction with High-Performance Liquid Chromatography for the Analysis of 1,4-benzodioxane-6-aldehyde in Eliglustat Tartrate Active Pharmaceutical Ingredient

Publication date: Available online 12 November 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Yixuan Cui, Di Liu, Jing Bian, Yuke Yang, Mengqiang Zhao, Ye JiangAbstractPotential genotoxic impurities (PGIs) are a series of compounds that could potentially damage DNA. Therefore, a sensitive method is needed for detection and quantification. The present work described and validated a method for the quantification of one PGI (namely 1,4-benzodioxane-6-aldehyde) in Eliglustat tartrate (EGT) active pharmaceutical ingredient (API) substances using dispersive liquid-liquid microextraction (DLLME) as sample preparation to remove matrix effect and detected by HPLC-UV. Parameters influencing the microextraction efficiency were systematically investigated. The combined application of DLLME and HPLC-UV provided the sensitivity of the method. The achieved limit of detection (LOD) and the limit of quantification (LOQ) were adequate for the specific purpose and found to be 1.29 µg g-1 and 2.58 µg g-1, respectively. This simple and effective methodology offers a key advantage in the ease of removing matrix effect and improves sensitivity obviously. In addition, no costly instrumentation and skilled personnel are needed when using this method, which is available and can be successfully implemented in routine factory drug quality control analysis.
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research