@article{
author = "Mijatović, Vesna and Zečević, Mira and Zirojević, Jelena",
year = "2023",
abstract = "The goal of this study was the optimization of chromatographic conditions and validation
of the isocratic RP-HPLC method for monitoring the stability of aripiprazole, identification and
quantitative analysis of aripiprazole and its degradation products in tablets.
In addition, robustness was tested by applying the methodology of experimental design.
The forced degradation study of aripiprazole was conducted in accordance with the ICH
guidelines. The stability of the active pharmaceutical substance was tested under the conditions
of hydrolysis in acidic, neutral and basic environments, thermal degradation, oxidation and
photolysis. The active pharmaceutical ingredient was degraded under oxidation conditions, and
the identity of the resulting degradation product, N-oxide, was confirmed. Under the other
conditions tested, the active pharmaceutical substance was found to be stable. The developed
method RP-HPLC allowed the separation of degradation products and aripiprazole and was
defined as a stability-indicating method. The proposed method was validated for qualitative and
quantitative analysis of aripiprazole and its degradation products. Accordingly, selectivity,
linearity, precision, accuracy, limit of detection, limit of quantification, and robustness of the
method were tested. The Box-Behnken experimental design was used in robustness testing., Cilj rada bio je optimizacija hromatografskih uslova i validacija izokratske HPLC metode
za praćenje stabilnosti aripiprazola, identifikacija i kvantitativna analiza aripiprazola i njegovih
degradacionih proizvoda u tabletama, kao i ispitivanje robusnosti predložene analitičke metode
primenom eksperimentalnog dizajna.
Studija forsirane degradacije aktivne farmaceutske supstance aripiprazola sprovedena je u
skladu sa ICH smernicama. Ispitivana je stabilnost aktivne supstance u uslovima hidrolize u
kiseloj, neutralnoj i baznoj sredini, termalne degradacije, oksidacije i fotolize. Aktivna supstanca
je pokazala degradaciju u uslovima oksidacije, pri čemu je potvrđen identitet nastalog proizvoda,
N-oksida, Pri ostalim ispitivanim uslovima, aktivna farmaceutska supstanca je pokazala
stabilnost. Kako je predložena RP-HPLC metoda omogućila efikasno razdvajanje degradacionih
proizvoda i aripiprazola, definisana je kao metoda za praćenje stabilnosti farmaceutskog
proizvoda.
Sprovedena je validacija predložene metode za istovremenu identifikaciju i kvantifikaciju
aripiprazola i njegovih degradacionih proizvoda. Tom prilikom su ispitani selektivnost,
linearnost, preciznost, tačnost, limit detekcije i limit kvantifikacije, a primenom Box-
Behnkenovog eksperimentalnog dizajna ispitana je i robusnost metode.",
publisher = "Savez farmaceutskih udruženja Srbije (SFUS)",
journal = "Arhiv za farmaciju",
title = "Development and validation of a stability- indicating RP-HPLC method for determination of aripiprazole and its degradation products, Razvoj i validacija RP-HPLC metode za praćenje stabilnosti u cilju određivanja sadržaja aripiprazola i njegovih degradacionih proizvoda",
volume = "73",
number = "3",
pages = "216-235",
doi = "10.5937/arhfarm73-44512"
}
