Integrated Quality by Design (QbD) and Quality Risk Management (QRM) based Liquid Chromatographic Method Development and Validation for Estimation of Capecitabine in Pharmaceutical Dosage Form

A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products

“…Subsequently, the control strategy must be updated throughout the lifecycle of the analytical method [44]. For instance, Panda et al [45] and Deidda et al [46] employed control charts with acceptance limits applied to Critical Method Variables involved in liquid chromatography methods.…”

“…the precision, lower limit of quantification and dosing range of the analytical method are introduced at the beginning in the elaboration of the ATP document to specify the expected measurement performances. Furthermore, depending on to the authors, the ATP document was exposed in multiple formats: with tables in [36,45,49,39] [50] or in simple texts in [44,43,48,37,51,46]. Very recently in [27], Jackson et al has detailed through three examples how to precisely fill in the ATP application form.…”

“…In [44,37], the authors implemented a four-step AQbD procedure for sample preparation and the improvement of a Liquid Chromatography coupled to Mass Spectrometry stabilityindicating method, respectively. One additional stage is considered in [51,45,46] for the optimization and validation of high-performance liquid chromatography techniques. The majority of AQbD schemes rely on a six-step process as in [43,39,49,53].…”

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“…Implementing quality by design to analytical method has multiple advantages compared to traditional method development and optimization. These include developing a regulated and robust analytical method for application throughout the lifecycle of a pharmaceutical product 7 . Quality by design is a modern, scientific approach that formalizes product design, automates manual testing, and streamlines troubleshooting 8 .…”

Analytical lifecycle management approach: Application to development of a reliable LC method for estimation of lacidipine

“…Once the ATP and CQAs are defined, the quality risk management (QRM) tools like fish‐bone diagram, control‐noise‐experimental (C‐N‐X) approaches are best utilized to identify the critical method variables (CMVs) out of method variables that demand further studies. The fishbone diagram effectively segregates various method variables, and the vital ones are further subjected to C‐N‐X approach . The variables are then systematically optimized using experimental designs for attaining desired performance .…”