TLCStability indicating chromatographic methods for determination of buflomedil in presence of its degradation products.

Simple, sensitive, selective and precise stability-indicating thin-layer chromatographic (TLC) and high-peR_formance liquid chromatographic (HPLC) methods were developed for the determination of Buflomedil (BFM) in presence of its acid induced degradation products. Complete degradation was carried out by refluxing 50 mg of pure BFM with 50 mL 5 N HCl for 4 hours and produce two main degradation products (1, 3, 5 Trimethoxybenzene and butane- pyrrolidinium salt). Methods were validated as per the International Conference on Harmonization guidelines ICH Q2A and Q2B. The TLC method employs aluminum TLC plates 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 (R_f= 0.55) and its degradation product (R_f =0.05), the chromatogram was scanned at 272 nm. The HPLC method utilizes a C₁₈ column (Zorbax, 150 mm × 4.6 mm, 5 µm) and a mobile phase consisting of methanol: water: acetonitrile: triethylamine (50:30:20:0.4, v/v/v/v, pH 6.5) at a flow rate of 0.7 mL min^-1 for the separation of Buflomedil (R_T=3.76) and its degradation product (R_T=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 inteR_ference from the excipients. [ABSTRACT FROM AUTHOR]