VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GLECAPREVIR AND PIBRENTASVIR BY USING ANALYTICAL QUALITY BY DESIGN (AQBD) METHOD

Abstract

The quantitative measurement of Glecaprevir and Pibrentasvir has been created using a simple, quick, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method. It is more difficult to analyse varying amounts of pharmaceutical active medicinal ingredients in dosage forms without interferences. Therefore, the objective of the current work is to estimate Glecaprevir and Pibrentasvir simultaneously by adopting an Analytical Quality by Design (AQbD), a rotatable central composite-based technique using RP-HPLC-based method development and validation. Glecaprevir and Pibrentasvir were separated by chromatography using a Kinetex RP-18 Column (100x4.6mm, 2.6µ) column and a mobile phase made up of Acetonitrile: 0.1% tri fluoro acetic acid in a ratio of 26.464:73.536 v/v. The flow rate was 1.0 ml/min, and a photodiode array detector operating at room temperature was used to detect absorption at 236 nm. ICH criteria have been used to validate the offered techniques' linearity, accuracy, precision, and other attributes. The degradation study's findings showed that the medications deteriorated in high-stress situations. The chemical and pharmaceutical sectors might easily implement this unique AQbD-based analytical technique for routine analysis without any regulatory constraints.