Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities
Original language description
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).
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
CB - Analytical chemistry, separation
OECD FORD branch
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Result continuities
Project
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Continuities
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Pharmaceutical and Biomedical Analysis
ISSN
0731-7085
e-ISSN
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Volume of the periodical
125
Issue of the periodical within the volume
June
Country of publishing house
NL - THE KINGDOM OF THE NETHERLANDS
Number of pages
9
Pages from-to
376-384
UT code for WoS article
000376474400045
EID of the result in the Scopus database
2-s2.0-84964433369