G. Anantha Siva Nageswara Rao

The objective of the present research work is to develop and validated analytical method for the determination of Darunavir in pure and tablet dosage form. A simple, rapid, precise, selective and accurate novel RP-HPLC method was developed and validated for separation and determination for the Darunavir in pure and tablet dosage form. Darunavir was analyzed by Zodiac C18, (250×4.6mm, 5µ), Shimadzu LC-20AT Prominence Liquid Chromatograph and mobile phase constituted of Triethylamine buffer: Acetonitrile (60:40 v/v). The pH of the buffer was adjusted to 4.5 with diluted ortho-phosphoric acid. The flow rate of mobile phase was 1.0 mL/min and the analysis was performed using UV-Visible detector at 260nm. The Darunavir was eluted with in 6 min and retention time was showed 2.753 min. The developed assay method was validated by the guidelines of ICH Q2R1.The method was found to be linear in the drug concentration range of 20 µg/mL -100 µg/mL. The value of correlation coefficient was found to be 0.999. Method was found good percentage recovery it indicate the method is highly accurate. The method has been successfully applied for determination of Darunavir in pharmaceutical dosage form in regular quality control analysis.