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2021, vol. 10, br. 1, str. 20-28
Studija fotostabilnosti tableta amlodipin besilata upakovanih u primarnoj ambalaži
aUniverzitet u Nišu, Tehnološki fakultet, Leskovac, Srbija
bPharmaceutical and Chemical Industry - Zdravlje Actavis, Leskovac
cUniverzitet u Beogradu, Farmaceutski fakultet, Srbija

e-adresasavicivana@tf.ni.ac.rs
Projekat:
Ministarstvo prosvete, nauke i tehnološkog razvoja Republike Srbije (institucija: Univerzitet u Nišu, Tehnološki fakultet, Leskovac) (MPNTR - 451-03-68/2020-14/200133)

Ključne reči: lek; fotodegradacija; kinetika; RP-HPLC; primarno pakovanje
Sažetak
U radu je validirana modifikovana stability-indicating RP-HPLC metoda za kvantitativnu analizu amlodipin besilata u prisustvu njegove nečistoće D (3-etil 5-metil 2-[(2-aminoetoksi)metil]-4-(2-hlorofenil)-6-metilpiridin-3,5-dikarboksilat). Metoda je primenjena za određivanje analita u tabletama i ozračenim uzrocima upakovanih u primarnoj ambalaži (Alu/PVC/PVDC blister pakovanje). Efikasno hromatografsko razdvajanje postignuto je upotrebom ZORBAX Eclipse XDB-C18 kolone (4,6×250 mm, 5 mm) sa izokratskim eluiranjem mobilne faze koja se sastojala od acetonitrila:metanola:rastvora trietilamina (15:35:50, v/v/v) (pH 3,0). Protok mobilne faze bio je 1 mL min-1, dok je detekcija amlodipin besilata vršena na 273 nm. Amlodipin besilat i nečistoća D su identifikovani pri retencionim vremenima 16,529 min i 2,575 min, respektivno. Linearnost metode sa koeficijentom determinacije 0,999 potvrđena je u opsegu koncentracija 10 - 75 µg mL-1 za amlodipin besilat. Granica detekcije bila je 0,2 µg mL-1, dok je granica kvantifikacije bila 0,66 µg mL-1. Nakon UV i Vis zračenja tableta upakovanih u primarnoj ambalaži, sadržaj amlodipin besilata smanjio se za 22,38% i 19,89%, respektivno. Prisustvo novih degradacionih proizvoda nije detektovano pri datim hromatografskim uslovima. Fotodegradacija amlodipin besilata sledila je kinetiku pseudo-prvog reda. Na osnovu vrednosti poluvremena degradacije (38,4 dana za UV zračenje i 43,3 dana za Vis zračenje) zaključeno je da je amlodipin besilat u tabletama ima zadovoljavajuću fotostabilnost nakon njegovog pakovanja u Alu/PVC/PVDC blister pakovanju.
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O članku

jezik rada: engleski
vrsta rada: izvorni naučni članak
DOI: 10.5937/savteh2101020S
primljen: 23.04.2021.
prihvaćen: 09.06.2021.
objavljen u SCIndeksu: 10.07.2021.

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