Development and Validation of HPLC analytical methods used for determination of assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tablets

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dc.authorscopusid15766716500
dc.authorscopusid6603768177
dc.contributor.authorYuce M.
dc.contributor.authorCapan Y.
dc.date.accessioned2024-06-12T10:27:54Z
dc.date.available2024-06-12T10:27:54Z
dc.date.issued2017
dc.description.abstractNew analytical methods have been developed and validated on high performance liquid chromatography (HPLC) to assess the assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tablets. Method development studies were performed on cyano column. Mobile phase of assay and content uniformity test consisted of mixture of 0.05 M phosphate buffer, pH 4.5 and methanol (40:60, v/v) adjusted to pH 4.0 with trifluoroacetic acid, whereas mobile phase of dissolution test consisted of mixture of 1 mM phosphate buffer and acetonitrile (50:50, v/v) adjusted to pH 2.0 with trifluoroacetic acid. Mobile phases were pumped at flow rate of 1.0 mL/min, ultraviolet-visible (UV) detector was operated at 254 nm, injection volume was set at 20 ?L, column temperature was held at 258C. Dissolution medium was 0.05 M phosphate buffer, pH 6.5 including 0.70% (w/v) polysorbate 20. Validation studies met acceptance criteria of system suitability, specificity, linearity and range, accuracy, precision, detection limit (LOD), quantitation limit (LOQ) and robustness parameters.en_US
dc.identifier.endpage367en_US
dc.identifier.issn0001-6837
dc.identifier.issue2en_US
dc.identifier.scopus2-s2.0-85016160330en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage357en_US
dc.identifier.urihttps://hdl.handle.net/20.500.14551/16972
dc.identifier.volume74en_US
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherPolish Pharmaceutical Societyen_US
dc.relation.ispartofActa Poloniae Pharmaceutica - Drug Researchen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectAssay; Candesartan Cilexetil; Content Uniformity; Dissolution; Method Validation; Tableten_US
dc.subjectCandesartan Hexetil; Carboxymethylcellulose; Hydroxypropylcellulose; Lactose; Macrogol 4000; Magnesium Stearate; Starch; Analytic Method; Article; Controlled Study; Drug Determination; Drug Release; Drug Solubility; High Performance Liquid Chromatography; Limit Of Detection; Limit Of Quantitation; Measurement Accuracy; Sensitivity And Specificity; Validation Studyen_US
dc.titleDevelopment and Validation of HPLC analytical methods used for determination of assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tabletsen_US
dc.typeArticleen_US

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