An Overview of Advances in the Chromatography of Drugs Impurity Profiling

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ALSaeedy M., Al-Adhreai A., Oncu-Kaya E. M., ŞENER E.

CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY, vol.53, no.7, pp.1455-1471, 2023 (SCI-Expanded)

• Publication Type: Article / Review
• Volume: 53 Issue: 7
• Publication Date: 2023
• Doi Number: 10.1080/10408347.2022.2032587
• Journal Name: CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY
• Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Aerospace Database, Aqualine, Aquatic Science & Fisheries Abstracts (ASFA), Biotechnology Research Abstracts, Chemical Abstracts Core, Chimica, Communication Abstracts, Compendex, EMBASE, Environment Index, Geobase, MEDLINE, Metadex, Civil Engineering Abstracts
• Page Numbers: pp.1455-1471
• Keywords: Degradation, drug substance, ICH Q3, impurity profiling, separation of impurities, RP-HPLC METHOD, POTENTIAL GENOTOXIC IMPURITIES, LIQUID-CHROMATOGRAPHY, QUANTITATIVE-DETERMINATION, DEGRADATION-PRODUCTS, FORCED DEGRADATION, PHENYLEPHRINE HYDROCHLORIDE, TABLETS IDENTIFICATION, MASS-SPECTROMETRY, ORGANIC IMPURITY
• Anadolu University Affiliated: Yes

Abstract

A systematic literature survey published in several journals of pharmaceutical chemistry and of chromatography used to analyze impurities for most of the drugs that have been reviewed. This article covers the period from 2016 to 2020, in which almost of chromatographic techniques have been used for drug impurity analysis. These chromatography techniques are important in the analysis and description of drug impurities. Moreover, some recent developments in forced impurity profiling have been discussed, such as buffer solutions, mobile phase, columns, elution modes, and detectors are highlighted in drugs used for the study. This primarily focuses on thorough updating of different analytical methods which include hyphenated techniques for detecting and quantifying impurity and degradation levels in various pharmaceutical matrices.