„Zelena“ RP-HPLC metoda za određivanje profila nečistoća amlodipina u tabletama

  • Olga Gigopulu Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Hrisanta Godzo Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Biljana Atanasovska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Marija Zafirova Gjorgievska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Center for Drug Quality Control
  • Ana Poceva Panovska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Jasmina Tonic-Ribarska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Jelena Acevska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Katerina Brezovska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
  • Natalija Nakov Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
DOI: https://doi.org/10.5937/arhfarm74-49799
Ključne reči: amlodipin, profil nečistoća, „zelena“ metoda, HPLC, procena ekološke prihvatljivosti

Sažetak


Porast nivoa svesti o važnosti očuvanja prirode podstakao je uvođenje koncepta zelene analitičke hemije (GAC), koji se odnosi na nekoliko važnih aspekata, uključujući održivi razvoj, uticaj na životnu sredinu i minimizaciju otpada. Cilj ovog istraživanja bio je da doprinese implementaciji ovog pristupa u farmaceutskoj industriji, zadržavajući pritom ključne aspekte i stroge zahteve kontrole kvaliteta lekova. Stoga je razvijena i optimizovana ekološki prihvatljiva i robusna metoda tečne hromatografije visokih performansi (HPLC) za određivanje srodnih supstanci amlodipina (AML) u filmom obloženim tabletama, uz upotrebu dizajna eksperimenata (DoE). Hromatografska separacija izvršena je na RP-select B koloni (250 x 4,0 mm, 5 μm), pri čemu je korišćena mešavina 0,04 M natrijum dihidrogen fosfat monohidrata (pH 4,0) i etanola (60:40 % v/v) kao mobilna faza. Optimizovani uslovi omogućili su separaciju dve određene nečistoće (nečistoća D i nečistoća F). Selektivnost metode potvrđena je upotrebom studija prinudne degradacije. Pristup analitičke ekološke skale i metrika AGREE potvrdili su da metoda odgovara principima GAC. Validirana metoda uspešno je primenjena za određivanje srodnih supstanci u tri uzorka sa tržišta, što pokazuje primenljivost ove metode u rutinskoj analizi.

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Objavljeno
2024/04/28
Broj časopisa
Vol. 74 Br. Notebook 2 (2024): Arhiv za farmaciju
Rubrika
Originalni naučni rad
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