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Determination of vortioxetine and its degradation product in bulk and tablets, by LC‐DAD and MS/MS methods
Author(s) -
Diego Marta,
Correa Diana,
Mennickent Sigrid,
Godoy Ricardo,
Vergara Carola
Publication year - 2018
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.4340
Subject(s) - chemistry , chromatography , triethylamine , acetic acid , degradation (telecommunications) , acetonitrile , hydrolysis , high performance liquid chromatography , organic chemistry , telecommunications , computer science
Vortioxetine hydrobromide (VOR), is a novel antidepressant used for the treatment of major depressive disorder. It has a chemical structure susceptible to degradation, therefore it is important to have suitable analytical methods to determine VOR in presence of its main degradation products (DP), because if the compound degrades, this could result in diminution of the therapeutic activity and safety. A simple HPLC method with photodiode array detection was developed and validated for determination of VOR in bulk and tablets, in the presence of its major DP. The drug was subjected to oxidative, hydrolytic, and photolytic stress conditions, showing significant degradation under oxidation with the formation of one DP, which was identified by ESI‐MS/MS. A C 18 column was used, with mobile phase consisting of acetonitrile and water with acetic acid and triethylamine in isocratic elution mode, with detection at 228 nm and 1.0 mL/min flow rate. The assay was linear in the 25–125 μg/mL concentration range. For precision, the RSD was <1.8%, the recovery was 100.0–101.6%, and the method demonstrated adequate selectivity. The method was successfully applied to quantify VOR in tablets. The results showed that the method is useful for routine analysis and for quality control purposes.