DEVELOPMENT AND VALIDATION OF A NEW HPLC BIOANALYTICAL INTERNAL STANDARD METHOD FOR THE ANALYSIS OF REMDESIVIRIN HUMAN PLASMA

Abstract

Remdesivir (RMDSVR) is a pro-drug of an ATP analog, with antiviral activity against RNA viruses. In 2016 RMDSVR is used in the treatment of Ebola and 2017 RMDSVR was tested against SARS-CoV-2. The HPLC analysis was performed on the Agilent 1100 series HPLC with Quaternary G1311 A pump, ChromosilC18 column (250 X 4.6 mm, 5μ) column, with a mixture of Acetonitrile, Methanol and 0.1% OPA in the ratio of 65:30:5 (v/v) as the mobile phase, at 0.8 mL/min flow rate and UV detection at 272 nm. Abacavir (ABVR) is considered an internal standard and the retention time was observed at 6.0 min and 9.1 min for RMDSVR and ABVR respectively. The calibration curve was obtained linearly in the concentration range of 10-70 ng/mL. the method was validated and all the validated parameters were within the acceptable limit confirms that the method is suitable for the analysis of RMDSVR in spiked human plasma.