Determination of guaifenesin in spiked human breast milk: HPLC-UV method development, validation, and uncertainty evaluation

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dc.authorid0000-0003-3666-8187
dc.authorid0000-0002-5840-7386
dc.authorid0000-0001-8455-1173
dc.contributor.authorCeylan, Burhan
dc.contributor.authorÖnal, Cem
dc.contributor.authorÖnal, Armağan
dc.date.accessioned2026-04-13T08:06:44Z
dc.date.available2026-04-13T08:06:44Z
dc.date.issued2025
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Meslek Bilimleri Bölümü, Analitik Kimya Ana Bilim Dalı
dc.description.abstractA simple, sensitive, and reliable isocratic reversed-phase high-performance liquid chromatography (HPLC UV) method was developed, validated, and applied for the quantitative determination of guaifenesin in spiked human breast milk. Chromatographic separation was achieved on a C18 column (150 x 4.6 mm, 5 µm) using a mobile phase composed of methanol and water (50:50, v/v), where the aqueous phase was acidified with orthophosphoric acid (pH=3.2). The flow rate was 0.8 mL min-1, and detection was performed at 230 nm. The method exhibited excellent linearity over the concentration range of 5.0-30.0 ng mL-1 with a correlation coefficient of r2=0.9999. Liquid-liquid extraction (LLE) was used for sample preparation and resulted in a mean relative recovery of 98.82% with an absolute recovery of 99.52%, while effectively minimizing matrix interferences associated with breast milk. Method validation was performed in accordance with European Medicines Agency (EMA) bioanalytical guidelines, including assessments of selectivity, accuracy, precision, sensitivity, robustness, and stability. The method demonstrated strong reproducibility, did not require an internal standard, and provided a short analysis time suitable for routine application. This study presents the first simple, cost-effective, and sensitive HPLC-UV method for the determination of guaifenesin in human breast milk, offering a valuable analytical tool for evaluating drug safety during lactation.
dc.identifier.citationCeylan, B., Önal, C., & Önal, A. (2025). Determination of guaifenesin in spiked human breast milk: HPLC-UV method development, validation, and uncertainty evaluation. Methods and Objects of Chemical Analysis, 20(4), pp. 324-328. https://doi.org/10.17721/moca.2025.324-328
dc.identifier.doi10.17721/moca.2025.324-328
dc.identifier.endpage328
dc.identifier.issn1991-0290
dc.identifier.issn2413-6166
dc.identifier.issue4
dc.identifier.scopus2-s2.0-105031053538
dc.identifier.scopusqualityQ4
dc.identifier.startpage324
dc.identifier.urihttps://doi.org/10.17721/moca.2025.324-328
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1396
dc.identifier.volume20
dc.identifier.wosWOS:001710374600010
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynak.otherESCI - Emerging Sources Citation Index
dc.institutionauthorÖnal, Cem
dc.institutionauthorid0000-0002-5840-7386
dc.language.isoen
dc.publisherTaras Shevchenko National University of Kyiv
dc.relation.ispartofMethods and Objects of Chemical Analysis
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectGuaifenesin
dc.subjectHPLC-UV
dc.subjectHuman Breast Milk
dc.subjectMethod Development
dc.titleDetermination of guaifenesin in spiked human breast milk: HPLC-UV method development, validation, and uncertainty evaluation
dc.typeArticle
dspace.entity.typePublication

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