Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 6, July 2007, pp.305-310
High-Performance Liquid Chromatographic Stability
Indicating Assay Method of Tianeptine Sodium with
Simultaneous Fluorescence and UV Detection
Alaa Khedr
Pharmaceutical Chemistry Department, Faculty of Pharmacy, King
Abdulaziz University, Jeddah, King Saudi Arabia.
The purpose of this work is to develop a sensitive,
selective, and validated stability-indicating HPLC assay of tianeptine
(TIA) in bulk drug and tablet form. TIA is subjected to different
stress conditions, including UV-light, oxidation, acid base–base
hydrolysis, and temperature. TIA and its possible degradation
products are analyzed on Agilent-Zorbax-XDB-C18 column using gradient
elution with acetonitrile and 0.02M sodium acetate (pH 4.2). The
samples are monitored simultaneously with photo-diode array at
254 nm and fluoroscence detector set to 350 nm (ex) and 425 nm
(em). TIA is integrated from its UV-chromatogram, and the photodecomposition
products are integrated from the fluoroscence-chromatogram. TIA
and its photodecomposition products are separated by TLC using
ethyl acetate–n-hexane–glacial acetic acid–methanol
(10.0:14.0:0.2:1.0, v/v) as developing system. One potential photodegradation
product is detected by fluoroscence in TIA-tablet form and separated
by TLC. The linear range of TIA is between 0.5 to 50 µg/injection
with limits of quantitation and detection values of 30 and 8 ng/injection,
respectively. The inter-assay percentage of deviation is not more
than 0.03%, and the day-to-day variation is not more than 0.1%.
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