Naslov
Validacija UPLC metode za određivanje onečišćenja u nepafenaku
(Validation of UPLC method for determination of impurities in nepafenac)

Autori
Runje, Mislav ; Vojčić, Nina ; Dujmić Vučinić, Željka ; Krizmanić, Irena ; Meštrović, Ernest ; Babić, Sandra

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Knjiga sažetaka "24. Hrvatski skup kemičara i kemijskih inženjera" / Ukić, Šime ; Bolanča, Tomislav - Zagreb : Hrvatsko društvo kemijskih inženjera i tehnologa (HDKI), 2015, 183-183

ISBN
978-953-6894-54-3

Skup
24. Hrvatski skup kemičara i kemijskih inženjera

Mjesto i datum
Zagreb, Hrvatska, 21.04.2015. - 24.04.2015

Vrsta sudjelovanja
Poster

Vrsta recenzije
Domaća recenzija

Ključne riječi
UPLC metoda ; nepafenak
(UPLC method ; nepafenac)

Sažetak
Nepafenac is described chemically as 2-amino-3- benzoylbenzeneacetamide manufactured as a 0.1% suspension for topical ophthalmic use [1] and it belongs to group of nonsteroidal anti- inflammatory drugs (NSAID). A novel stability indicating reverse phase ultra-performance liquid chromatographic (UPLC) method has been developed for determination of Nepafenac along with six impurities, which are 2- aminobenzophenone, Cl-thionepafenac, Thionepafenac, Cl-Nepafenac, Hydroxy Nepafenac and Cyclic Nepafenac, and validated as per ICH recommendations [2]. The developed LC method is validated with respect to specificity, LOD, LOQ, linearity, precision, accuracy and robustness. The % RSD of Nepafenac during the method precision study was within 2.0% and the % RSD values of the area of 2- aminobenzophenone, Cl-thionepafenac, Thionepafenac, Cl-Nepafenac, Hydroxy Nepafenac and Cyclic Nepafenac in the related substance method precision study were within 5.0%. The resolution between Nepafenac and six potential impurities is found to be greater than 2.0. Regression analysis shows as R-value (correlation coefficient) is greater than 0.999 for Nepafenac and all impurities. This method is capable to detect the impurities of Nepafenac at a level of 0.003% with respect to test concentration of 1.0 mg/mL. The developed UPLC method is stability indicating which can be used to carry out the analysis of Nepafenac in routine analysis of production samples and stability samples.

Izvorni jezik
Engleski

Znanstvena područja
Kemija

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