High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture
Yıl: 2021 Cilt: 9 Sayı: 3 Sayfa Aralığı: 264 - 270 Metin Dili: İngilizce DOI: 10.14235/bas.galenos.2020.4372 İndeks Tarihi: 10-10-2021
High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture
Öz: Objective: This study aimed to develop and validate a method usinga high-performance liquid chromatography (HPLC) to perform aquantitative analysis of nebivolol (NEB) and amlodipine (AML)along with some related substances in the synthetic mixture.Methods: The separation in the described chromatographic systemwas accomplished using a mobile phase consisting of a mixture ofacetate buffer (pH: 4.5) and acetonitrile and a HPLC C18 column(150 mm x 4.6 mm, 2.6 μm) with gradient elution on a consistentflow rate of 1.3 mL/min. Photodiode array detection was carriedout at a wavelength of 265 nm. According to The InternationalConference on Harmonisation guidelines, the drug was exposed tovarious stress conditions; including photolysis, oxidation, thermaldegradation and hydrolysis under acidic, basic and neutral mediums.Results: Ranges of detection and quantitation limits weredetermined to be 0.2-10.0 μg.mL-1 and 0.25-10.0 μg.mL-1 forNEB and AML, respectively. The relative standard deviation valueswithin and between days precision were determined to be <2%. Forall substances, the average recovery values were determined withinthe range of 98.00%-101.50%.Conclusion: We conclude that this developed analytical procedureapplies to the quality control of drug formulations.
Anahtar Kelime: Nebivolol ve Amlodipin ve Bazı İlgili Bileşiklerinin Sentetik Karışımlarda HPLC ile Analizi
Öz: Amaç: Bu çalışma, nebivolol (NEB) ve amlodipinin (AML) kantitatif analizini yapmak için yüksek performanslı sıvı kromatografisi (HPLC) kullanarak bir yöntem geliştirmeyi ve validasyonunu amaçlamıştır Yöntemler: Kromatografik sistemdeki ayırma, asetat tamponu (pH: 4,5) ve asetonitril karışımından oluşan bir mobil faz kullanılarak, 1,3 mL/dakika akış hızında, C18 kolonda (150 mm x 4,6 mm, 2,6 m) gerçekleştirildi. Diyot sıralı dedektör 265 nm dalga boyuna ayarlandı. Uluslararası Uyum Konferansı yönergelerine uygun olarak ilaç, çeşitli stres koşullarına maruz bırakılmıştır. Bunlar; fotoliz, oksidasyon, termal bozunma ve asidik, bazik ve nötr ortamlar altında hidrolizdir. Bulgular: NBV ve AMV için kantitasyon limit aralıkları sırasıyla 0,2-10,0 g/mL-1 ve 0,25-10,0 g/mL-1 olarak belirlenmiştir. Gün içi ve günler arası kesinlik bakımından RSD değerlerinin %2’den düşük olduğu belirlenmiştir. Analizlenen tüm maddeler için ortalama geri kazanım değerlerinin %98,00-%101,50 aralığında olduğu belirlenmiştir. Sonuç: Geliştirilen analitik sürecin ilaç formülasyonlarının kalite kontrolü için uygulanabilir olduğu sonucuna vardık
Anahtar Kelime: Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
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| APA | Önal C, Aluc K, Onal A, Çetin Aluç Ç (2021). High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. , 264 - 270. 10.14235/bas.galenos.2020.4372 |
| Chicago | Önal Cem,Aluc Kadir,Onal Armagan,Çetin Aluç Çiğdem High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. (2021): 264 - 270. 10.14235/bas.galenos.2020.4372 |
| MLA | Önal Cem,Aluc Kadir,Onal Armagan,Çetin Aluç Çiğdem High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. , 2021, ss.264 - 270. 10.14235/bas.galenos.2020.4372 |
| AMA | Önal C,Aluc K,Onal A,Çetin Aluç Ç High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. . 2021; 264 - 270. 10.14235/bas.galenos.2020.4372 |
| Vancouver | Önal C,Aluc K,Onal A,Çetin Aluç Ç High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. . 2021; 264 - 270. 10.14235/bas.galenos.2020.4372 |
| IEEE | Önal C,Aluc K,Onal A,Çetin Aluç Ç "High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture." , ss.264 - 270, 2021. 10.14235/bas.galenos.2020.4372 |
| ISNAD | Önal, Cem vd. "High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture". (2021), 264-270. https://doi.org/10.14235/bas.galenos.2020.4372 |
| APA | Önal C, Aluc K, Onal A, Çetin Aluç Ç (2021). High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. Bezmiâlem Science, 9(3), 264 - 270. 10.14235/bas.galenos.2020.4372 |
| Chicago | Önal Cem,Aluc Kadir,Onal Armagan,Çetin Aluç Çiğdem High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. Bezmiâlem Science 9, no.3 (2021): 264 - 270. 10.14235/bas.galenos.2020.4372 |
| MLA | Önal Cem,Aluc Kadir,Onal Armagan,Çetin Aluç Çiğdem High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. Bezmiâlem Science, vol.9, no.3, 2021, ss.264 - 270. 10.14235/bas.galenos.2020.4372 |
| AMA | Önal C,Aluc K,Onal A,Çetin Aluç Ç High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. Bezmiâlem Science. 2021; 9(3): 264 - 270. 10.14235/bas.galenos.2020.4372 |
| Vancouver | Önal C,Aluc K,Onal A,Çetin Aluç Ç High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture. Bezmiâlem Science. 2021; 9(3): 264 - 270. 10.14235/bas.galenos.2020.4372 |
| IEEE | Önal C,Aluc K,Onal A,Çetin Aluç Ç "High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture." Bezmiâlem Science, 9, ss.264 - 270, 2021. 10.14235/bas.galenos.2020.4372 |
| ISNAD | Önal, Cem vd. "High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture". Bezmiâlem Science 9/3 (2021), 264-270. https://doi.org/10.14235/bas.galenos.2020.4372 |
