The RP-HPLC method development of Doxofylline was tested in an ODS C18 column based on the results of the trials. Different ratios of the different mobile phase compositions, such as methanol: water, acetonitrile: water, and potassium dihydrogen orthophosphate buffer: acetonitrile, were employed. An analytical approach was developed by experimenting with different chromatographic settings. The optimal approach was chosen for the development and validation of Doxofylline in tablet dosage form after all of the above strategies were compared. A simple, accurate, specific and rugged reverse phase liquid chromatographic method was developed for the estimation of Doxofylline in bulk and tablet dosage form. A RP Inertsil ODS, having dimensions of 150x4.6mm and particle size of 5µ in isocratic mode, with mobile phase containing a mixture of 10mM Ammonium acetate: Acetonitrile in the proportion (50:50 v/v). The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluent were monitored at 220 nm. The method was developed and then validated for system applicability, linearity, specificity, precision, accuracy, robustness, limit of detection and limit of quantification, and stability of the solution. Chromatograms demonstrate Doxofylline specificity. This approach had good separation between all peaks and no interference. It indicates that there was no interference from impurities and also shows that the suggested procedures did not conflict with regularly used excipients and additives included in the tablet dosage form. The medicine complies with Beer's rule, according to the linearity table.2. In the 50â150 μg/ml range, the calibration plot for Doxofylline was determined to be linear, and the correlation coefficient was 0.999.The accuracy of the approach is demonstrated by the findings displayed in accuracy table 6, which showed that the recovery values of pure medication from the solution ranged from 98.0% to 102%.
