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Stability Indicating Validated Chromatographic Methods for Determination of Buflomedil in Presence of its Degradation Products

Hesham Salem, Azza Aziz Moustafa, Maha Hegazy and Omnia Ali

Simple, sensitive, selective and precise stability-indicating thin-layer chromatographic (TLC) and high-performance liquid chromatographic (HPLC) methods for the determination of Buflomedil (BFM) in pharmaceutical tablets were developed and validatedas per the International Conference on Harmonizationguidelines. The TLC method employs aluminum TLCplates precoated with silica gel 60F254 as the stationary phase and Butanol: ammonia: triethylamine (8:0.5:0.5, v/v/v) as the mobile phase to give compact spots for Buflomedil (Rf=0.55) and its degradation product (Rf=0.05), the chromatogram was scanned at 272 nm. The HPLC method utilizes a C18 column and amobile phase consisting of methanol: water: acetonitrile: triethylamine (50:30:20:0.4, v/v, pH 6.5) at a flow rate of 0.7 mL min-1 for the separation of Buflomedil (tR=3.76) and its degradation product (tR=2.117). Quantitation was achieved with UV detection at 272 nm. The methods were validated in terms of accuracy, precision, linearity, limits of detection, and limits of quantification. Buflomedil was exposed to acid hydrolysis and analyzed by the proposed methods in presence of its degradation products. As the methods could effectively separate the drugs from their degradation products, these techniques can be employed as stability-indicating methods that have been successively applied to pharmaceutical formulations without interference from the excipients.