Simultaneous RP-HPLC Estimation, Validation and Stability Indicating Assay of Two-Component Tablet Formulation Containing Grazoprevir and Pibrentasvir

The determination of a two-component tablet formulation containing grazoprevir and pibrentasvir for method development and validation has been done using the reverse-phase high-performance liquid chromatography (RP-HPLC) method as per International Council of Harmonization (ICH) guidelines. Analytical grade acetonitrile and 0.01 N of potassium dihydrogen phosphate buffer were used as mobile phase while Kromasil C18 column was opted for separation. In order to elute the analyte a flow rate of 1-mL/min having 260 nm λ has been maintained. An RT of 2.909 and 2.358 minutes while linearity concentration range from 25 to 150 μg/mL and 10 to 60 μg/mL was obtained for grazoprevir and pibrentasvir, respectively, with 4.4 resolution. Both had a high correlation coefficient of 0.999. The limit of quantification was 0.24 and 0.09 μg/mL, while the detection limit at 0.72 and 0.27 μg/mL was noticed for grazoprevir and pibrentasvir, respectively. For grazoprevir and pibrentasvir, the regression equation was determined to be y = 16332x + 5313.1 and y = 17261x + 601.95, correspondingly