Nova HPLC metoda za istovremeno određivanje empagliflozina i dapagliflozina: Razvoj, validacija, testiranje robusnosti i procena ekološke prihvatljivosti
Sažetak
Empagliflozin (EMPA) i dapagliflozin (DAPA) se uglavnom preporučuju za lečenje dijabetesa tipa 2 i srčane insuficijencije. Na osnovu principa zelene analitičke hemije razvijena je jednostavna, brza i pouzdana HPLC metoda za određivanje oba analita u aktivnim supstancama. Razvijena je izokratska metoda, koja obuhvataprimenu kolone C18, sa mobilnom fazom koja se sastoji od samo 30% organskog modifikatora (ACN), dok je preostalih 70% HPLC voda. Analiza je obavljena u roku od 4 min sa protokom od 1,20 mL/min, dok je talasna dužina detekcije 230 nm. Metoda je potom validirana u skladu sa smernicama ICH Q2 (R1) i svi ispitivani parametri bili su unutar propisanih granica. Potom je robusnost metode evaluirana primenom faktorskog eksperimentalnog dizajna. Na kraju, ekološka prihvatljivost predložene metode procenjena je korišćenjem alata za procenu analitičke „zelenosti“ (Analytical GREEness – AGREE). Predložena metoda može se koristiti za analizu EMPA i DAPA u aktivnim supstancama, sa potencijalnom primenom u relevantnim doziranim oblicima.
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