Procena merne nesigurnosti primenom top-down i bottom-up pristupa za tačno određivanje sadržaja meloksikama u injekcionim farmaceutskim oblicima

  • Dino Karpicarov Univerzitet "Goce Delčev", Fakultet za medicinske nauke, Štip, Severna Makedonija
  • Ivana Mitrevska Univerzitet "Goce Delčev", Fakultet za medicinske nauke, Štip, Severna Makedonija
  • Paulina Apostolova Univerzitet "Goce Delčev", Fakultet za medicinske nauke, Štip, Severna Makedonija
  • Marija Arev Univerzitet "Goce Delčev", Fakultet za medicinske nauke, Štip, Severna Makedonija
  • Zorica Arsova Sarafinovska Univerzitet "Goce Delčev", Fakultet za medicinske nauka, Štip, Severna Makedonija; Institut za javno zdravlje Republike Severne Makedonije, Skoplje, Srbija
  • Marija Darkovska Sarafimovska Univerzitet "Goce Delčev", Fakultet za medicinske nauke, Štip, Severna Makedonija
  • Branka Dražić Univerzitet u Beogradu - Farmaceutski fakultet, Katedra za opštu i neorgansku hemiju, Beograd, Srbija
  • Jasmina Tonic Ribarska Institut za primenjenu hemiju i farmaceutsku analizu, Farmaceutski fakultet, Univerzitet „Sv. Kiril i Metodij“, Skoplje, Severna Makedonija
  • Biljana Gjorgjeska Univerzitet "Goce Delčev", Fakultet za medicinske nauke, Štip, Severna Makedonija
DOI: https://doi.org/10.5937/arhfarm75-63142
Ključne reči: bottom-up pristup, meloksikam, merna nesigurnost, top-down pristup

Sažetak


Mernа nesigurnost ima ključnu ulogu u obezbeđivanju pouzdanosti, tačnosti i regulatorne usklađenosti analitičkih rezultata u farmaceutskoj kontroli kvaliteta. Ovo istraživanje predstavlja sveobuhvatno poređenje Top-down i Bottom-up pristupa za procenu nesigurnosti povezane sa kvantitativnim određivanjem meloksikama u injekcionim dozama korišćenjem validirane HPLC metode. Top-down pristup, zasnovan na podacima validacije metode, dao je proširenu nesigurnost od ±0,336 mg po injekciji, dok je Bottom-up pristup (koji uključuje nesigurnosti od zapreminske opreme, referentnih standarda i molarne mase) proizveo širu vrednost od ±0,646 mg po injekciji. Rezultati ističu komplementarnu prirodu oba pristupa i podržavaju integraciju njihovih pojedinačnih prednosti radi unapređenja robusnosti procene nesigurnosti. Predložena metodologija je primenljiva i na druge metode u okviru farmaceutske kontrole kvaliteta.

 

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Objavljeno
2025/12/25
Broj časopisa
Vol. 75 Br. Notebook 6 (2025): Arhiv za farmaciju
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Originalni naučni rad
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