Abstract
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.
Highlights
Instability of pharmaceuticals affects both the safety andefficacy of drug therapy
Stability-indicating methods have been extended to include determination of BFM in presence of its degradation products, our review of the literature indicated that these methods are much sensitive and no such thin-layer chromatographic (TLC)-densitometric method has been described for determination of BFM in presence of its degradation products
A TLC densitometric method was used for the determination of BFM by separation from their degradation products, depending on the difference in Rf values
Summary
Appropriate analyticalstability-indicating methods which allow accurate andprecise drug quantitation in the presence of its degradationproducts are needed in order to assess the stability ofpharmaceuticals. The development of stabilityindicatingmethods has increased enormously, and is evenbeing extended to drug combinations. Buflomedil HCl (Figure 1), 4-(1-pyrrolidinyl)-1-(2,4,6trimethoxyphenyl)-1-butanone hydrochloride, is a vasoactive agent which increase the peripheral and cerebral blood flow in ischaemic tissues of patients with vascular diseases at the microcirculatory level [1] It is rapidly absorbed from the gastrointestinal tract, reaching maximal plasma concentration within 1.5-4 h. Only few methods were determined of BFM in presence of its degradation products
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