A VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF DOXOFYLINE IN PURE AND PHARMACEUTICAL FORMULATIONS

Abstract

A novel reverse phase high performance liquid chromatographic method (RP-HPLC) was developed and validated for the determination of doxofylline (DXF) in pharmaceutical formulations. Agilent 1100 series HPLC instrument equipped with variable wavelength programmable UV-Visible detector and a chromosil C18 (250mm x 4.6mm, 5$\mu $m) column with an auto injector was used for the present investigation. A volume of 20$\mu $L of working standard of concentration 25$\mu $g/mL was injected into the chromatographic system, the component was separated by using the mobile phase of the mixture of potassium dihydrogen phosphate buffer of pH 5.5 and acetonitrile in the ratio 75:25(v/v) at a flow rate of 1.0 mL/min and the detection of the components was carried out at a wavelength of 275nm. Chemstation software was used for the data acquisition through out the analysis. The system suitable parameters such as number of theoretical plates, tailing factor and resolution were found to be satisfactory. The retention time of the component was found to be at 4.814 minutes. The proposed method was validated in terms of precision, accuracy, linearity, limit of detection, limit of quantification, robustness and ruggedness. The developed method was found to be rapid, simple and sensitive hence it could be used as an alternative method in assay of the doxofylline in any pharmaceutical industries.