Abstract
A validated stability indicating RP-HPLC assay of doxofylline was developed by separating its related substances and degradants on Lichrocart®C18 (250mm×4.6mm; 5μm) column using 10mM ammonium acetate and acetonitrile as a mobile phase in a gradient mode of elution at a flow rate of 1.0mL/min at 30°C. The column effluents were monitored by a photo diode array detector set at 274nm. The method was validated in terms of accuracy, precision and linearity as per ICH guidelines. The limits of quantification of doxofylline and impurities were obtained in the range of 0.19–0.36μg/mL. Forced degradation of doxofylline was carried out under acidic, basic, thermal, photo, peroxide conditions and the degradation products were isolated and characterized by ESI-MS/MS, 1H and 13C spectroscopy. The method was successfully applied not only to quantify related substances and degradation products but also assay of doxofylline in bulk drugs. The recoveries of doxofylline and impurities were in the range of 99.00–100.05% and 97.83–99.86% respectively.
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