Development and validation of an HPLC method for quantification of solifenacin in spiked human breast milk

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dc.authorid0000-0003-3666-8187
dc.authorid0000-0002-3401-9186
dc.authorid0000-0002-5840-7386
dc.authorid0000-0001-8455-1173
dc.contributor.authorCeylan, Burhan
dc.contributor.authorÇayci, Meltem
dc.contributor.authorÖnal, Cem
dc.contributor.authorÖnal, Armağan
dc.date.accessioned2025-11-21T13:03:55Z
dc.date.available2025-11-21T13:03:55Z
dc.date.issued2025
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Meslek Bilimleri Bölümü, Analitik Kimya Ana Bilim Dalı
dc.description.abstractAn efficient and reliable reversed phase high performance liquid chromatography (HPLC) method was established and validated for the quantitative analysis of solifenacin succinate in fortified human breast milk samples. Chromatographic separation was carried out on a C18 column (150 × 4.6 mm, 5 μm particle size) and a isocratic mobile phase composed of acetonitrile and phosphate buffer (pH 3.5) in a 65:35 (v/v) ratio. The flow rate was at 1.1 mL/min, and detection was performed at 225 nm using a ultraviolet (UV) detector. The method exhibited excellent linearity in the range of 1.0 to 40.0 ng/mL (r² = 0.9999). The validation process was performed in accordance with European Medicines Agency (EMA) bioanalytical guidelines, and included selectivity, accuracy, precision, sensitivity, recovery, robustness, and stability assessments. The liquid-liquid extraction (LLE) procedure used for sample pretreatment provided satisfactory recovery (mean: 99.32 %) and minimized matrix interferences from breast milk. The method showed high reproducibility, did not require an internal standar, and offered a rapid analysis time of approximately 3.4 minutes. This study offers a simple, cost-effective, and sensitive HPLC-UV method for monitoring solifenacin levels in breast milk matrices, providing a valuable tool for evaluating drug safety during lactation.
dc.identifier.citationCeylan, B., Çayci, M., Önal, C., & Önal, A. (2025). Development and validation of an HPLC method for quantification of solifenacin in spiked human breast milk. Analytical Science & Technology, 38(5), pp. 333-339.
dc.identifier.endpage339
dc.identifier.issn2288-8985
dc.identifier.issn1225-0163
dc.identifier.issue5
dc.identifier.scopusqualityQ4
dc.identifier.startpage333
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1196
dc.identifier.volume38
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.publisherKorean Society of Analytical Sciences
dc.relation.ispartofAnalytical Science & Technology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.subjectSolifenacin
dc.subjectHPLC-UV
dc.subjectValidation
dc.subjectHuman Breast Milk
dc.subjectMethod Development
dc.titleDevelopment and validation of an HPLC method for quantification of solifenacin in spiked human breast milk
dc.typeArticle
dspace.entity.typePublication

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