Simultaneous Determination And Validation Of Darunavir Ethanolate And Ritonavir In Binary Mixture By Liquid Chromatography

A simple and accurate method to determine Darunavie ethanolate (DRV) and ritonavir (RTV), in binary mixture, was developed and validated using liquid chromatography (LC). The LC separation was achieved on a Phenomenex Luna C18 column (250 mm, 4.6mm i.d., 5μm), in the isocratic mode using acetonitrile: water (60: 40, v/v), pH adjusted to 3.2 ± 0.02 with formic acid at a flow rate of 1 mL/min. The retention times were about 5.02 and 7.60 min for DRV and RTV, respectively. Quantification was achieved with UV-visible detector at 245 nm over the concentration range of 6-60 and 2-20 μg/mL for DRV and RTV respectively, with mean recoveries of 99.54-100.18 % and 99.16-100.20 % for DRV and RTV, respectively. The method was validated, and was found to be simple, specific, accurate, precise and robust. The method was successfully applied for the determination of DRV and RTV in binary mixture without any interference from common excipients.