ED Primena eksperimentalnog dizajna za razdvajanje lekova HPLC metodom; pregledni rad

DoE u HPLC analitici lekova

  • Jevrem Stojanović Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za analitiku lekova
  • Jovana Krmar Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za analitiku lekova https://orcid.org/0000-0002-5469-9633
  • Ana Protić Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za analitiku lekova https://orcid.org/0000-0002-6304-1913
  • Bojana Svrkota Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za analitiku lekova
  • Nevena Đajić Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za analitiku lekova https://orcid.org/0000-0003-4420-9781
  • Biljana Otašević Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za analitiku lekova
Ključne reči: eksperimentalni dizajn, analitika lekova, tečna hromatografija pod visokim pritiskom, razvoj i validacija analitičke metode

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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2021/08/27
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