Simultaneous Determination of Bamifylline and Its Major Metabolite AC-119 by RP-HPLC

In the present study a simple, sensitive accurate and fast method for the simultaneous determination of bamifylline and its major metabolite AC-119 by isocratic reversed-phase HPLC is developed. Caffeine is used as internal standard for quantitation analysis and the method was applied to the determination of bamifylline in pharmaceutical preparations (tablets and suppositories). The isocratic elution was performed with methanol - 0.05 M ammonium acetate (67:33 v/v) at a flow rate of 1.5 ml/min, using a Lichrosorb Cjg analytical column 250×4.6 mm, 10 μm. Absorbance was monitored at 277 nm. Total analysis time was approximately 5 min. Data with respect to precision and accuracy, and limits of detection are reported and discussed. The described method can be readily utilised for pharmaceutical products analysis and pharmacokinetic studies as well.