Development and validation of an HPLC method using an experimental design for analysis of amlodipine besylate and enalapril maleate in a fixed-dose combination

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dc.authorid0000-0001-9549-8857en_US
dc.authorid0000-0003-0744-0968en_US
dc.contributor.authorYaşın, Diren Sarısaltık
dc.contributor.authorBingül, Alev Arslantürk
dc.contributor.authorKaraküçük, Alptuğ
dc.contributor.authorTeksin, Zeynep Şafak
dc.date.accessioned2023-03-16T07:10:23Z
dc.date.available2023-03-16T07:10:23Z
dc.date.issued2021en_US
dc.departmentDicle Üniversitesi, Eczacılık Fakültesi, Eczacılık Teknolojisi Bölümüen_US
dc.description.abstractObjectives: The aim of this study was to develop and optimize a simple, cost-effective, and robust high-performance liquid chromatography (HPLC) method by taking an experimental design approach to the assay and dissolution analysis of amlodipine besylate and enalapril maleate from a fixed-dose combination tablet. Materials and Methods: The chromatographic analysis was performed on a C18 column (4.6x250 mm id., particle size of 5 mu m). The injection volume was 5 mu L, and the detection wavelength was 215 nm. A Box-Behnken design was used to test the robustness of the method. The flow rate (1, 1.2, and 1.4 mL/min), column temperature (25 degrees C, 30 degrees C, and 35 degrees C), methanol ratio of the mobile phase (5, 10, and 15%), and pH of the mobile phase (2.8, 3, and 3.2) were selected as independent variables. The method was validated according to International Conference on Harmonization guidelines. Dissolution of the tablets was performed by using USP apparatus 2 and analyzed using the optimized HPLC method. Multivariate linear regression analysis and ANOVA were used in the statistical evaluation. Results: Linear models were fitted for all variables. The flow rate was the most significant factor affecting the APIs' concentrations. The optimized method included the following parameters: Column temperature of 25 degrees C, 10% methanol as the mobile phase, pH of 2.95, and flow rate of 1.205 mL/min. Retention times were 3.8 min and 7.9 min for enalapril and amlodipine, respectively. The method was found to be linear in the range of 0.8-24 mu g/mL (R-2 >0.999) and 1.6-48 mu g/mL (R-2 >0.999) for amlodipine and enalapril, respectively. Both APIs were dissolved more than 85% within 10 min. Conclusion: The experimental design was proved as a useful tool for the determination and separation of enalapril maleate and amlodipine besylate in dosage forms. The optimized method can be used for in vitro performance and quality control tests of fixed-dose tablet combinations containing enalapril maleate and amlodipine besylate.en_US
dc.identifier.citationYaşın, D.S., Bingül, A.A., Karaküçük, A. ve Teksin, Z.Ş. (2021). Development and validation of an HPLC method using an experimental design for analysis of amlodipine besylate and enalapril maleate in a fixed-dose combination. Turkish Journal of Pharmaceutical Sciences, 18(3), 306-318.en_US
dc.identifier.doi10.4274/tjps.galenos.2020.89725
dc.identifier.endpage318en_US
dc.identifier.issn1304-530X
dc.identifier.issn2148-6247
dc.identifier.issue3en_US
dc.identifier.pmid34157820
dc.identifier.scopus2-s2.0-85109611965
dc.identifier.scopusqualityQ2
dc.identifier.startpage306en_US
dc.identifier.trdizinid481673
dc.identifier.urihttps://cms.galenos.com.tr/Uploads/Article_39785/TJPS-18-306-En.pdf
dc.identifier.urihttps://hdl.handle.net/11468/11415
dc.identifier.volume18en_US
dc.identifier.wosWOS:000756356000008
dc.identifier.wosqualityN/A
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.indekslendigikaynakTR-Dizin
dc.institutionauthorYaşın, Diren Sarısaltık
dc.institutionauthorBingül, Alev Arslantürk
dc.language.isoenen_US
dc.publisherGalenos Publicationen_US
dc.relation.ispartofTurkish Journal of Pharmaceutical Sciences
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAmlodipineen_US
dc.subjectEnalaprilen_US
dc.subjectDesign of experimenten_US
dc.subjectHPLCen_US
dc.subjectFixed-dose combinationen_US
dc.titleDevelopment and validation of an HPLC method using an experimental design for analysis of amlodipine besylate and enalapril maleate in a fixed-dose combinationen_US
dc.titleDevelopment and validation of an HPLC method using an experimental design for analysis of amlodipine besylate and enalapril maleate in a fixed-dose combination
dc.typeArticleen_US

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