RP-HPLC method development and validation for the simultaneous estimation of glecaprevir and pibrentasvir in bulk and tablet dosage form

RP-HPLC method development and validation for the simultaneous estimation of glecaprevir and pibrentasvir in bulk and tablet dosage form - Development and Validation of the RP-HPLC Method for Concurrent Estimation of Glecaprevir and Pibrentasvir in Tablet Dosage Forms. Pibrentasvir and glicaprevir's medicinal dosage forms were identified using the RP-HPLC analytical method. The chromatographic separation was performed using an Altima C18 150 x 4.6 mm, 5 µm and a mobile phase consisting of buffer 0.1% OPA: Acetonitrile (60:40) (v/v). 0.1% OPA was the buffer utilised in this procedure. Without derivatisation, detection was done at 260.0 nm with a flow rate of 1 ml/min. Both pibrentasvir and glicaprevir were shown to be linear over the 45–105 µg/mL and 125–325 µg/mL ranges, respectively. Using the linear regression equation y = 9124x + 494.7 (r?2; = 0.998) for Glecaprevir and y = 13172x + 8283 (r?2; = 0.998) for Pibrentasvir, it was shown that this linearity was -134 for both drugs. The calibration curve produced a linear area under the curve for Glecaprevir and Pibrentasvir. In accordance with the schedule, the computed retention time was 3.140 (2%) and 2.249 minutes. Glecaprevir and Pibrentasvir were found to have respective % RSDs of 0.3 and 0.4. The anticipated LOD and LOQ values of 0.040, 0.121, and 0.0791, 0.241%, respectively, were obtained from this validation. The range of recovery (%Recovery) was 99.63% to 99.53%. The recovery (%Recovery) ranged from 99.63% to 99.53%. Following statistical validation, the robustness of the proposed technique ranged from 1.236 to 2.636. The recovery range of 99.63 to 99.53% suggests that the strategy was suitable. Regular quality control testing in industries could make use of the suggested RP-HPLC technology due to its affordability, accuracy, precision, and ease of use. Keywords: Glecaprevir, Pibrentasvir, HPLC, Retention time, Degradation studies.