ABSTRACT:
Elbasvir a NS5A inhibitor is used in combination of Grazoprevir (NS3/4A protease inhibitor) for the treatment of chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV) under the trade name Zepatiar®. A stability indicating reverse phase HPLC method was developed and validated for the determination of Elbasvir and Grazoprevir in tablet dosage form. A waters Alliance HPLC with Zorbax eclipse XDB C18 (250 x 4.6 mm) 3.5µ columnwas used for chromatographic separation. A mobile phase consisting of potassium dihydrogen phosphate buffer pH adjusted to 4.0: acetonitrile (40:60v/v) with a flow rate of 1.0 mL/min was used, the UV detection was carried out at 260 nm. The established method was linear, accurate and precise over the range of 12.5 to 75 µg/mL with a regression equation of Y=20782X+2849.4 and correlation coefficient of 0.9995for elbasvir and linear over the range of 25-150 µg/mL with a regression equation of Y=14897X+20611 and correlation coefficient of 0.9992for Grazoprevir. The validated method demonstrated high sensitivity, accuracy, precision, selectivity and robustness. The method demonstrated high selectivity in presence of degradants produced during the stress conditions when Elbasvir and Grazoprevir were subjected to acid, alkali, oxidation, thermal and photolytic degradation.