AQBD Assisted Development and Validation of a Stability-Indicating UPLC Method for Assay of Pirtobrutinib in Bulk and Pharmaceutical Formulation
Objective: Utilizing the principles of Analytical Quality by Design (AQbD), a stability-indicating UPLC method for estimating Pirtobrutinib in bulk and formulation was developed. Critical method variables were identified by risk assessment using an Ishikawa diagram, and multivariate optimization of the experimental con...