Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11160%2F16%3A10328688" target="_blank" >RIV/00216208:11160/16:10328688 - isvavai.cz</a>
Výsledek na webu
<a href="http://www.sciencedirect.com/science/article/pii/S0731708516302060" target="_blank" >http://www.sciencedirect.com/science/article/pii/S0731708516302060</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jpba.2016.04.020" target="_blank" >10.1016/j.jpba.2016.04.020</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities
Popis výsledku v původním jazyce
Agomelatine is one of the newest antidepressants. Due to a different mechanism of action it offers a completely new approach in the treatment of depressive disorders. Two chromatographic methods for determination of agomelatine and its impurities were developed. The separations on UHPSFC system were accomplished using stationary phase based on BEH 2-EP and gradient elution with CO2 and methanol containing 20 mM ammonium formate and 5% of water. The UHPLC separations were performed on stationary phase BEH Shield RP18. The mixture of acetonitrile and methanol in ratio 1:1 and ammonium acetate buffer pH 9.5 were used as mobile phase. Both developed methods were properly validated in terms of linearity, sensitivity (LOD, LOQ), accuracy and precision according to ICH guidelines. The UHPSFC method was linear in the range 0.25-70 p.g/ml for all analytes with method accuracy >= 97.4% and >= 100.2% and method intra-day precision RSD <= 2.4 and <= 0.8 for impurities and API (active pharmaceutical ingredient), respectively. The UHPLC method was linear in the range 0.1-10 mu g/ml for all analytes except three impurities for which the linear range was larger 0.1-25 mu g/ml. Method accuracy >= 95.7% and >= 95.2% and method intra-day precision RSD <= 2.6 and <= 1.5 were found for impurities and API, respectively. The measurement of tablet samples was performed and the selected parameters of the methods were compared. In conclusion, both methods were appropriate for the determination of agomelatine and its impurities in pharmaceutical quality control (QC), although the UHPSFC method was found as more convenient especially in the method development phase. The advantages of newly developed UHPSFCPDA (photo diode array detector) method were its environmental friendliness due to the mobile phase used, a very good resolution, selectivity and high speed of analysis (total time of separation was 4.1 min).
Název v anglickém jazyce
Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities
Popis výsledku anglicky
Agomelatine is one of the newest antidepressants. Due to a different mechanism of action it offers a completely new approach in the treatment of depressive disorders. Two chromatographic methods for determination of agomelatine and its impurities were developed. The separations on UHPSFC system were accomplished using stationary phase based on BEH 2-EP and gradient elution with CO2 and methanol containing 20 mM ammonium formate and 5% of water. The UHPLC separations were performed on stationary phase BEH Shield RP18. The mixture of acetonitrile and methanol in ratio 1:1 and ammonium acetate buffer pH 9.5 were used as mobile phase. Both developed methods were properly validated in terms of linearity, sensitivity (LOD, LOQ), accuracy and precision according to ICH guidelines. The UHPSFC method was linear in the range 0.25-70 p.g/ml for all analytes with method accuracy >= 97.4% and >= 100.2% and method intra-day precision RSD <= 2.4 and <= 0.8 for impurities and API (active pharmaceutical ingredient), respectively. The UHPLC method was linear in the range 0.1-10 mu g/ml for all analytes except three impurities for which the linear range was larger 0.1-25 mu g/ml. Method accuracy >= 95.7% and >= 95.2% and method intra-day precision RSD <= 2.6 and <= 1.5 were found for impurities and API, respectively. The measurement of tablet samples was performed and the selected parameters of the methods were compared. In conclusion, both methods were appropriate for the determination of agomelatine and its impurities in pharmaceutical quality control (QC), although the UHPSFC method was found as more convenient especially in the method development phase. The advantages of newly developed UHPSFCPDA (photo diode array detector) method were its environmental friendliness due to the mobile phase used, a very good resolution, selectivity and high speed of analysis (total time of separation was 4.1 min).
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
CB - Analytická chemie, separace
OECD FORD obor
—
Návaznosti výsledku
Projekt
—
Návaznosti
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2016
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Journal of Pharmaceutical and Biomedical Analysis
ISSN
0731-7085
e-ISSN
—
Svazek periodika
125
Číslo periodika v rámci svazku
June
Stát vydavatele periodika
NL - Nizozemsko
Počet stran výsledku
9
Strana od-do
376-384
Kód UT WoS článku
000376474400045
EID výsledku v databázi Scopus
2-s2.0-84964433369