Merkezi Kompozit Dizayn Kullanılarak Kapesitabin TayiniiçinRPLC Yönteminin Geliştirilmesi ve Validasyonu

Tersfaz sıvı kromatografi (RPLC) yöntemi, merkezi kompozit dizayn (CCD) kullanılarak kapesitabinin analizi için geliştirilmiş ve valide edilmiştir. Metot üç faktörle (mobil faz organik modifiyer derişimi, mobil faz pH’sı ve kolon sıcaklığı) Minitab programı kullanılarak optimize edilmiştir. Optimum kromatografik koşullar, Derringer’in istenebilirlik fonksiyonu kullanılarak belirlenmiştir. CCD'nin yardımıyla tayin edilen ayırmanın optimum koşulları: (1) Mobil faz: asetonitril-suikili karışımı oranı 40:60 (%h/h), (2) kolon sıcaklığı 32oC ve mobil fazın pH'sı 7,5'dur. Çalışma, YMC triart C18 (150x4,6 mm I.D, 3m) kolonda ve 1 mL/dakika akış hızında gerçekleştirilmiştir.Geliştirilen sıvı kromatografik yöntemin ICH parametrelerine göre validasyonu gerçekleştirilmiştir.

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