Development and Validation of UV-Spectrophotometric Method for Estimation of Doxofylline in Bulk and Tablets

Abstract

Doxofylline is a xanthine derivative and it has its application as a bronchodilator in different pulmonary conditions like asthma and COPD (chronic obstructive pulmonary disease). The research was conducted with the objective to develop and validate a simple, easy, rapid and cost-effective UV-Spectrophotometric method to estimate the amount of doxofylline in bulk and tablets. The validating parameters and methodology were selected and performed according to ICH and USP guidelines. In the accuracy study, the mean % recovery was within the limit (100.20%) with %RSD 0.77. The mean of % assay and %RSD of intra-assay precision study was found 99.81 and 0.79 respectively with only 0.57% variation between two analysts in intermediate precision study. The linearity study demonstrated the value of the correlation coefficient is 0.9999 whereas the robustness studies showed a slight but negligible variation of absorbance while changing different operating parameters. In system suitability study, the %RSD was found less than 2.00%. According to the specificity study, there were no placebo and diluent effect on the absorbance measurements.