Validated and Sensitive Liquid Chromatography-Spectrophotometric Method for the Estimation of Doxofylline in Bulk Drug Formulation

Abstract

Two selective methods were developed and validated for the determination of Doxofylline in tablet dosage form. One method is based on UV Spectroscopy were UV spectra of Doxofylline recorded. The absorption maximum (λmax) were observed at 274\nm which obeys Beer's law over the concentration range from 2 to 20μg/ml andshows linearity The validation method proposed for Recovery studies was further confirmed by at 50%, 100% and 150%. The percentage recovery values from 98% w/w, 100.5% w/w, 99.70% w/w, 99.96% w/w. This shows a good index of accuracy and reproducibility of the study. The another method is based on the Reverse phase HPLC method was developed by using Methanol: Disodium phosphate in the ratio of 30: 70 as a mobile phase and stationary phase is Phenomenox Luna C18 (5micron, 250 4.6mm) column. Flow rate of doxofylline was 1.0ml/min. The uv detector was operated at 274nm. The method was validated for accuracy, linearity, precision, specificity and limit of quantification. The recovery studies showed that the observed percentage recovery of Doxofylline was found to be 98.4 to 98.9%. The retention time of Doxofylline was found to be 12.77 min. The developed method was precise and accurate which was evident from the analytical data and recovery studies.