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Research & Reviews: Journal ofPharmaceutical Analysis | ISSN : 2320-0812 Euro Pharma Chemistry & Future Pharma 2019
June 27-28, 2019 | Amsterdam, Netherlands
12th World congress on Joint Event
4 th Pharmaceutical Chemistry Conference Future Pharma
Volume 08
Novel stability indicating LCmethods for determination of tasimelteon
Tasimelteon (TAS) is a melatonin receptor agonist compound, which is
currently in use for the treatment of non-24-hour sleep–wake disorder
in totally blind people. In this study, novel stability-indicating LC methods
have been developed for the determination of TAS besides its degradation
products. Three different LC set-ups were used within this study. Initially, an
LC-PDA instrument was developed for quantification of TAS; the separation
of TAS from its degradation products was achieved on an Ascentis® Express
F5-bonded fused-core silica particle column using the mobile phase of
acetonitrile: acetate buffer (0.025 M, pH 4.5): water (40:10:50, v/v/v); the
elution was performed in isocratic mode at 0.8 mL min−1 flow rate, detecting
the analytes at 281 nm. In addition, an alternative method was developed
by using an LC-DAD-MS/MS instrument; the responses of DAD and MS/
MS detectors were used as separate analytical signals for TAS and other
compounds. A second-generation C18-bonded monolithic silica column
was used as stationary phase in this method, while the mobile phase was
a mixture of 0.1% (v/v) formic acid in water and 0.1% (v/v) formic acid
in acetonitrile (60: 40 (v/v), pH=2.5). The instrumental and analytical
performances of all three set-ups were compared in terms of validation
parameters mentioned in ICHQ2(R1) guideline. On the other hand, a new
degradation product was identified using an LC/MS-IT-TOF instrument.
In conclusion, determination of TAS besides its degradation products and
identification of a novel degradation product was successfully performed
using the protocols reported in this study.
Biography
Serkan Levent is a Lecturer in Anadolu University and also a PhD student at the Department
of Analytical Chemistry of the same university. He has published more than 30 papers in highly
reputed journal, which are mostly indexed in Science Citation Index of Thomson-Reuters.
Serkan Levent et al., Pharmaceutical Analysis 2019, Volume 08
Serkan Levent
Anadolu University, Turkey
Co-Authors
Saniye Ozcan, Aysun Geven, Yusuf
Ozkay and Nafiz Oncu Can
Anadolu University, Turkey