Research Article
K. Parameswara Rao, B. V. Rame
Abstract
Reversed phase liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the determination of Darunavir in pure and formulations. Separation was achieved with symmetry C18-Column using the mobile phase of Phosphate Buffer (pH adjusted to 2.5) and Acetonitrile in the ratio 70:30 v/v, at a flow rate of 1.5 mL/min and UV detection was performed at 255 nm. The developed method was linear over a range of 5.0-25 μg/mL for Darunavir. The accuracy of the developed method was demonstrated at three concentration levels in the range of 50–150 % and the recovery of Darunavir was found to be in the range of 99.22–99.83 %. The developed method was said to be simple, selective and accurate and is useful for the assay of Darunavir in dosage forms and can be further employed in the quality control analysis of bulk manufacturing and formulations units.