Öz
Sonuç:
Geliştirilen analitik sürecin ilaç formülasyonlarının kalite kontrolü için uygulanabilir olduğu sonucuna vardık.
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.
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.
Amaç:
Bu çalışma, nebivolol (NEB) ve amlodipinin (AML) kantitatif analizini yapmak için yüksek performanslı sıvı kromatografisi (HPLC) kullanarak bir yöntem geliştirmeyi ve validasyonunu amaçlamıştır.
Anahtar Kelimeler: Nebivolol, amlodipin, yüksek basınçlı sıvı kromatografisi, validasyon, sentetik karışım
Kaynakça
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