Design of Analytical Method Validation Protocol Evaluating Environmental Monitoring of AND Contamination on Surfaces Based on Cleaning Validation Procedures: A Multi Component RP-UHPLC Method

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dc.contributor.authorDemircan Yildirim, Fatma
dc.contributor.authorEkmekci, Ismail
dc.date.accessioned2023-02-10T08:45:33Z
dc.date.available2023-02-10T08:45:33Z
dc.date.issued2022en_US
dc.departmentEnstitüler, Fen Bilimleri Enstitüsü, İş Sağlığı ve Güvenliği Ana Bilim Dalıen_US
dc.description.abstractEnvironmental monitoring of anti-neoplastic drug (AND) residues in workplaces is crucial to limit exposure to workers who handle with them. Although wipe sampling is the most appropriate methodology to evaluate the risk, conflicting results are also reported due to the lack of standardized and validated procedures. In this study, procedures for surface contamination of ANDs in workplaces are presented, with a focus on sampling, sample preparation and instrumentation. The analytical method validation parameters are designed to comply with requirements of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 Good Manufacturing Practice (GMP) for active pharmaceutical ingredients. Additionally, the study provides a simple, specific, rapid and multi-component analytical method to evaluate seven ANDs that are Gefitinib, Imatinib, Dasatinib, Axitinib, Erlotinib, Nilotinib and Sorafenib at very low concentration levels, simultaneously. Quantitative, precise and reproducible results obtained from the study show that environmental monitoring procedure and analytical method validation protocol presented in the study can be used to reduce and monitor occupational exposure risk to ANDs in wokplaces.en_US
dc.identifier.doi10.1093/chromsci/bmac071en_US
dc.identifier.endpage936en_US
dc.identifier.issue10en_US
dc.identifier.pmid35980296en_US
dc.identifier.scopus2-s2.0-85144588372en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage926en_US
dc.identifier.urihttps://hdl.handle.net/11467/6198
dc.identifier.urihttps://doi.org/10.1093/chromsci/bmac071
dc.identifier.volume60en_US
dc.identifier.wosWOS:000841947200001en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherNLM (Medline)en_US
dc.relation.ispartofJournal of chromatographic scienceen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.titleDesign of Analytical Method Validation Protocol Evaluating Environmental Monitoring of AND Contamination on Surfaces Based on Cleaning Validation Procedures: A Multi Component RP-UHPLC Methoden_US
dc.typeArticleen_US

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