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Stability-Indicating HPTLC Method for Analysis of Moclobemide, and Use of the Method to Study Degradation Kinetics
Authors:Shital S Patel  Rajesh S Keshalkar  Mandev B Patel
Institution:1. Department of Pharmaceutical Chemistry, Shri S. K. Patel College of Pharmaceutical Education and Research Centre, Ganpat University, Mehsana, Gujarat, 411038, India
2. Department of Pharmaceutics, Parul Institute of Pharmacy, Limda, Baroda, India
3. Department of Pharmaceutical Chemistry, Nootan Pharmacy College, Visnagar, Gujarat, 384315, India
Abstract:A sensitive, selective, precise, and stability-indicating HPTLC method for analysis of moclobemide in the bulk drug and in formulations has been established and validated. Aluminium TLC plates precoated with silica gel 60 F254 were used with benzene–methanol–40% ammonia 7:3:0.1 (v/v) as mobile phase. Densitometric analysis was performed in absorbance mode at 238 nm. Compact bands were obtained for moclobemide (R F 0.67 ± 0.02; n = 6). The drug was subjected to acidic and alkaline hydrolysis, oxidation, dry heat treatment, and photodegradation. The drug undergoes degradation under acidic, basic, and oxidising conditions. The degradation products were well resolved from the pure drug with significantly different R F values, so the method can be regarded as stability-indicating. Response to moclobemide was a linear function of amount in the range 50–600 ng per band, with a correlation coefficient, r 2, of 0.9967 ± 0.51. LOD and LOQ, determined experimentally, were 10 and 30 ng per band, respectively. Statistical analysis proves the method is repeatable and specific for analysis of moclobemide. The method was used to investigate the kinetics of alkaline degradation. The Arrhenius plot was constructed and the activation energy calculated.
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