December 31, 2018 Journal article Open Access

THE NOVEL USE OF PENTABROMOBENZYL COLUMN FOR SIMULTANEOUS DETERMINATION OF THREE ANTIVIRAL DRUGS, SOFOSBUVIR WITH DACLATASVIR OR LEDIPASVIR IN THEIR TABLET DOSAGE FORM AND SPIKED HUMAN PLASMA

Maha Abd-Elrahman. Sultan1, Maha Mahmoud Abou El-Alamin1, Sherif F Hammad 2, Alastair W. Wark3, Marwa Mohamed Azab*1.

New sensitive, selective and specific reversed phase high performance liquid chromatographic methods for the simultaneous determination of two antiviral mixtures, sofosbuvir (SOF) with ledipasvir (LED) or with daclatasvir (DAC) has been developed. The proposed methods were optimized and validated on Pentabromobenzyl (PBr) analytical column (5 μm; 4.6 mm × 150 mm). The analysis of the studied drug combinations was determined within 8 min for SOF and LED mixture and 5 min for SOF and DAC mixture, using photodiode array detector (PDA). The mobile phase consists of 30 mM phosphate buffer pH (3.0), methanol and acetonitrile (20:20:60, v/v) for SOF and LED mixture and 40 mM phosphate buffer (pH 3.6) and acetonitrile (50:50, v/v) for SOF and DAC mixture. A linear response was observed for all the studied compounds in the range of the concentration studied with mean percentage recoveries of 100.16% ± 1.48 and 100.07% ± 1.82 for SOF and LED, respectively and 100.05 % ± 1.38 and 100.81% ± 1.36 for SOF and DAC, respectively. The proposed methods were successfully applied for the determination of these drugs in their pharmaceutical dosage forms and in human plasma samples.