Technivie® is a fixed-dose combination of ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor and is indicated in combination with ribavirin for the treatment of patients with genotype-4 chronic hepatitis C virus (HCV) infection without cirrhosis. Developing a single analytical method for the estimation of individual drugs in a quad pill is very challenging, due to the formation of drug-drug and drug-excipient interactions. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single HPLC method for the simultaneous quantitative determination of four antiviral agents in fixed pharmaceutical dosage form. Chromatographic separation of the four antiviral drugs was achieved by using a gradient elution at a flow rate of 1.5 mL/min on Inertsil ODS 3V C18 column (250m×4.6mm, 5?m particle size, 100Å pore size) at ambient temperature. Mobile phase A of the gradient solvent system was KH2PO4 (0.03M) in 1000 ml of water and by adjusting the pH to 3.2 with dilute ortho-phosphoric acid and mobile phase B was Methanol and water in the ratio of 85:15 v/v. UV detection at 265 nm was employed to monitor the analytes. A linear response was observed for Paritaprevir over the concentration range 30180 ?g/ mL for Paritaprevir, 5-30?g/ mL of Ombitasvir and 20-120 ?g/ mL Ritonavir. Limit of detection (LOD) for Paritaprevir, Ombitasvir and Ritonavir were 0.075?g/mL, 0.125?g/mL, 0.00575?g/mL and 3?g/mL respectively. Limit of quantification (LOQ) for Paritaprevir, Ombitasvir and Ritonavir were 0.225?g/mL, 0.375?g/mL, and 0.015?g/mL respectively.
