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• W2336824676 abstract "Vorikonazol VOR immun sistemi baskilanmis hastalarda olusabilecek invazif aspergilloz tedavisinde kullanilan onemli bir ilactir. Bu calismada, intravenoz infuzyon ve tablet formulasyonlarindan VOR tayini icin bir ultra akis sivi kromatografisi UFLC yontemi gelistirildi ve ICH rehberlerine uygun olarak valide edilmistir. Ic standart Fenazopiridin IS ile birlikte VOR analizi ACE Excel 2 C18 50 mm x 3 mm id, 2 um analitik kolonu kullanilarak gerceklestirilmistir. Bilesenler metanol ve su 50: 50, v/v iceren hareketli faz ile 0.40 mL/dk akis hizinda elue edildi. Dizi diyot dedektor dalga boyu 255 nm olarak ayarlanmistir. Bu kromatografik sartlar altinda VOR ve IS alikonma zamanlari sirasiyla 6.09 and 7.35 dk ’dir. VOR icin LOD ve LOQ degerleri 50 ng/mL and 100 ng/mL olarak bulunmustur. Gelistirilen metot VOR icin 0.5 - 100 μg/mL araliginda dogrusaldir. Gun ici- gunler arasi calismalarda en yuksek BSS degeri %1.81 olarak bulunmustur. VOR icin ortalama geri kazanim 100.64 ± 0.48% RSD: 1.18%, n=6 dir. Intravenoz infuzyon ve tablet preparasyonlardan VOR analizi icin gelistirilmis yontemin; farkli analizci ve kromatografik kosullarinda kucuk degisiklikler acisindan, saglam ve dayanikli oldugu bulunmustur. Gelistirilen yontemin farmakopelerde belirtilen kriterlere dayanan sistem uygunluk degerleri, VOR’un intravenoz infuzyon ve tablet preparasyonlardan tayini icin uygun oldugunu ortaya koymaktadir. VOR analizi icin gelistirilen ve valide edilen UFLC yonteminin uzun donem guvenirlik calismalari Shewhard kalite kontrol kartlari ile gosterilmistir. Yontem rutin kalite kontrol calismalari icin basit, duyarli, kesin, dogru olup dusuk akis hizindan dolayi az solvent kullanimi ile ucuzdur." @default.
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• W2336824676 date "2013-06-01" @default.
• W2336824676 modified "2023-09-27" @default.
• W2336824676 title "P-2: A FULLY VALIDATED CHROMATOGRAPHIC DETERMINATION OF VORICONAZOLE FROM INFUSION SOLUTION AND TABLET" @default.
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