Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry


Simultaneous determination of pentoxifylline and its impurities in tablet dosage forms by RP-HPLC

Author(s): Boyka G. Tsvetkova, Ivanka P. Pencheva, Plamen T. Peikov

A reversed-phase high-performance liquid chromatographic (RP-HPLC) method with UV detection was proposed for separation of pentoxifylline and its impurities from tablet dosage forms. The best separation was achieved on a LiChrosorb C18, 250 mm x 4.6 mm, 5 μm column at a detector wavelength of 274 nm. Isocratic regimen usage with 80:20:1:3 (v/v/v/v) mixture of water, methanol, o-phosphoric acid and tetrahydrofuran as a mobile phase at a flow rate of 1 ml/min enabled acceptable resolution of pentoxifylline, in large excess, from possible impurities, in a short elution time (15 min). Analytical parameters linearity, accuracy, precision and selectivity were determinated by validation procedure in accordance with ICH requirements and found to be satisfactory. Overall, the proposed method was found to be simple, rapid, precise and accurate for quality control of pentoxifylline and its impurities in dosage forms and in raw materials.

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