Show simple item record

dc.contributor.authorYüksel, Bayram
dc.contributor.authorŞen, Nilgün
dc.contributor.authorBinay, Emrullah
dc.contributor.authorÖncü, Tuna
dc.date.accessioned2023-10-10T12:48:31Z
dc.date.available2023-10-10T12:48:31Z
dc.identifier.citationÖncü T., Yüksel B., Binay E., Şen N., "LC-MS/MS Investigation of nitrosamine impurities in certain Sartan group medicinal products available in Istanbul, Türkiye Investigation des impuretés des nitrosamines par LC-MS/MS dans certains médicaments du groupe Sartan disponibles à Istanbul, Turquie", Annales Pharmaceutiques Francaises, 2023
dc.identifier.issn0003-4509
dc.identifier.othervv_1032021
dc.identifier.otherav_266c7932-1441-4e05-814f-54002e6b100d
dc.identifier.urihttp://hdl.handle.net/20.500.12627/190266
dc.identifier.urihttps://doi.org/10.1016/j.pharma.2023.08.002
dc.identifier.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85169040769&origin=inward
dc.description.abstractNitrosamines (NAs) are molecules that include the nitroso functional group. In 2018, the US Food and Drug Administration (FDA) received its first report of NAs in pharmaceuticals. The fact that NA impurities are likely human carcinogens is relevant to these compounds. Furthermore, prolonged exposure to NA contaminants above safe limits may raise the risk of cancer. The goal of this article was to assess the amounts of six different NAs in Sartan group medicines purchased from formal pharmacies in Istanbul, Türkiye, using a validated LC-MS/MS assay. An LC-MS/MS-based analytical assay was undertaken. The separation was performed with a HR ODS 150 mm × 3.0 mm and 5-analytical columns, providing effective separation of major peaks from NA impurities. In mobile phase A, formic acid was 0.10% in water, while in mobile phase B, formic acid was 0.10% in methanol. The flow rate was 0.4 mL/minute, and the total runtime was 18 minutes with the gradient elution mode. The validation was conducted in line with ISO/IEC 17025 requirements. Up to 100 μg/L, linearity was determined using correlation coefficients (r2 > 0.995) for all NAs. The limit of quantification values for all NAs analyses were below 1.0 μg/L. The mean recovery value obtained during the spike experiment was 95.18%, demonstrating the accuracy of the procedure. In addition, the accuracy was shown by a certified reference analysis, which yielded relative standard deviation and relative error values of 1.82% and 3.34%, respectively. During the intermediate precision testing, bias and relative standard deviation were 0.96 and 2.87%, respectively. Of the 75 study samples involving Sartan group medical products, no nitrosamine impurities were detected, demonstrating that pharmaceutical companies have adequate medication safety precautions in place in accordance with FDA and European Medicines Agency (EMA) regulations published to prevent NA contaminants in human medicinal products.
dc.language.isoeng
dc.subjectTemel Eczacılık Bilimleri
dc.subjectYaşam Bilimleri
dc.subjectSağlık Bilimleri
dc.subjectTemel Bilimler
dc.subjectFarmakoloji
dc.subjectFarmasötik bilim
dc.subjectTıp
dc.subjectEczacılık
dc.subjectTROPİKAL TIP
dc.subjectFarmakoloji ve Toksikoloji
dc.subjectKlinik Tıp
dc.subjectYaşam Bilimleri (LIFE)
dc.subjectKlinik Tıp (MED)
dc.subjectFARMAKOLOJİ VE ECZACILIK
dc.titleLC-MS/MS Investigation of nitrosamine impurities in certain Sartan group medicinal products available in Istanbul, Türkiye Investigation des impuretés des nitrosamines par LC-MS/MS dans certains médicaments du groupe Sartan disponibles à Istanbul, Turquie
dc.typeMakale
dc.relation.journalAnnales Pharmaceutiques Francaises
dc.contributor.departmentShimadzu Middle East Africa , ,
dc.contributor.firstauthorID4551578


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following Collection(s)

Show simple item record