A robust stability indicating HPLC technique for evalution of Pibrentasvir and Glecaprevir in tablet dosage form

Abstract

When liver cells gets infected and vandalized, the condition is termed as Hepatitis. HCV therapy is performed with mixture of drugs. For the combined evaluation of Pibrentasvir and Glecaprevir in tablets, a rapid, selective and robust HPLC technique stability indicating was developed herein this work. Analysis was executed by Cosmicsil, with dimensions 250 mm by 4.6 mm column and mobile phase possessing KH₂PO₄ with 0.1M, 65 ml and 35 ml of methanol and 230 nm of PDA analysis. Elution times were found out as were 1.663 min and 2.249 min, for Pibrentasvir and Glecaprevir respectively with linear ranges 20µg/ml, 60 µg/ml and 50 µg/ml, 150 µg/ml, respectively having detection limits as 0.190 µg/ml and 0.207  µg/ml and quantization limits as 0.634 µg/ml and 0.690 µg/ml. This method is explicit having RSD values as 0.097% Pibrentasir & 0.232% Glecaprevir showing an accuracy of between 98.82 and 100.07% for Pibrentasir 99.31, Glecaprevir 100.45% recovery values. During the investigation of degradation, peaks elution times of degradants greatly varied with the elution times of Glecaprevir and Pibrentasvir thus, proving method‘s power of stability indication and specificity. The validation and degradation stability studies were carried out according to ICH and ICH Q1B Guidelines.