ED Primena eksperimentalnog dizajna za razdvajanje lekova HPLC metodom; pregledni rad
DoE u HPLC analitici lekova
Sažetak
Dizajn eksperimenata (DoE) je nezaobilazan alat u savremenoj analizi lekova budući da istovremeno balansira niz hromatografskih parametara kako bi se osiguralo optimalno razdvajanje u tečnoj hromatografiji pod visokim pritiskom (HPLC). Prikazana je teorijska osnova DoE i data su detaljna uputstva za njegovu primenu u HPLC ispitivanjima u farmaciji. Naročito se govori o klasifikaciji brojnih tipova dizajna i njihovim mogućnostima za racionalizaciju različitih faza tokom procesa razvoja HPLC metode, kao što su izbor najuticajnijih faktora, optimizacija faktora i procena robusnosti metode. Dodatno, sumirana je primena DoE kao sastavnog dela koncepta ugradnje kvaliteta u proizvod u domenu razvoja analitičkih metoda (AQbD) zasnovanih na HPLC tehnici. Takođe su prikazana i nedavna dostignuća u primeni DoE u razvoju LC metoda koje su pogodne za ispitivanje stabilnosti lekova, kao i LC-MS metoda. U budućoj perspektivi, preporučeno je izvođenje ispitivanja kvantitativnog odnosa između strukture i retencionog ponašanja (QSRR) analita u HPLC sistemu na osnovu podataka dobijenih primenom DoE.
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