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1450491 
Journal Article 
Stress Degradation Assessment of Lamotrigine Using a Validated Stability-Indicating HPTLC Method 
Michail, K; Daabees, HM; Beltagy, Y; Abdel-Khalek, M; Khamis, MM 
2013 
WOS:000309827900001 
In this work, a sensitive and stability-indicating HPTLC
method for the determination of lamotrigine is presented. According to the International
Conference on Harmonization guidelines Q1A, lamotrigine was exposed to a variety of stress
conditions; these include heating in acidic, basic and neutral media. Its stability towards
oxidative stress, humidity, high temperature and direct sunlight was also examined. Separation of
the drug from its forced degradation impurities was achieved using TLC silica gel plates and a
mobile phase composed of ethyl acetate: methanol: ammonia. The linear regression analysis of the
data obtained for the correlation plots showed good linearity over the concentration range of 10
-300 ng/spot. The forced degradation studies showed that lamotrigine is susceptible to
degradation under acidic, basic, neutral and oxidative conditions, among which alkaline-induced
hydrolysis had the highest degradative potential. Alternatively, the drug was stable under heat,
humidity, and daylight stress factors. In order to assess the purity and stability of the drug in
tablet formulations, the developed method was applied to the analysis of commercial tablets in
brand and generic products. The obtained results showed that the degradation of the drug has not
occurred in the marketed formulation that were analyzed by the described methodology. 
IRIS
• Methanol (Non-Cancer)
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