Naslov
UHPLC study on the degradation profiles of active substance XX in the eye drops subjected to heat and filtration sterilization methods

Autori
Valentić, Iva ; Buratović, Maša ; Štanfel, Danijela

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

Izvornik
Book of Abstracts 19th International Symposium on Separation Sciences, New Achievements in Chromatography / - , 2013, 94-94

Skup
19th International Symposium on Separation Sciences, New Achievements in Chromatography

Mjesto i datum
Poreč, Hrvatska, 25.09.2013. - 28.09.2013

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
degradation profil ; eye drop ; filtration ; sterilization

Sažetak
Products intended to be sterile should be terminally sterilised by heating . Where it is not possible to carry out terminal sterilisation by heating due to formulation instability, an alternative method of terminal sterilisation, like filtration, should be taken to utilise. The purpose of this study was to determine the impact of heat sterilisation on the eye drops stability and to assist in the selection of the optimal sterilisation method. The ultra high performance liquid chromatography (UHPLC) method was developed and validated for determination of degradation products of the active substance in the eye drops. The developed method was linear over the concentration range of 0.05 - 4 µg/ml with acceptable correlation coefficient of ≥ 0.995. The accuracy was within the 5% bias (98.5 – 104.0%). The limit of qualification was 0.02 µg/ml. Repeatability yielded coefficient of variation (CV) of less than 7% (0.47%) and intermediate precision provided CV value of less than 20% (13.13%). Two samples of the eye drops, one sterilized by heat and other sterilized by filtration were conducted to the UHPLC study for degradation profiles. All results of impurities were low and below ICH reporting threshold which is 0.1% for tested eye drops. More impurities and higher content of impurities was determined on the chromatogram of the sample sterilised by heat. The method validation study proven that the method is accurate and precise. Thanks to the high resolution and sensitivity of the UHPLC method, the method has been applied successfully to determine the influence of the different sterilization procedures on the drug product stability.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija

POVEZANOST RADA