Analytical Method Development of Stability Indicating UPLC Methods for Antipsychotic Drugs by QbD Approach

Abstract

Analytical testing becomes increasingly important in pharmaceutical development including risk assessment, process monitoring, control, and continuous quality checks since there is a large increase in the population and new diseases. newlineIf proper scientific studies are not conducted during development phase, it may lead to failure or investigation during stability studies. Method Development strategy plays an important role in quality and cost of the product. Modern approaches like QbD (Quality by Design) make it possible to develop simple, cost effective and robust methods. QAbD is a systematic process used to develop products starting with pre-defined objectives, with an emphasis on understanding the products and controlling them professionally with solid science. Significance of method developed by QbD approach is, as per the FDA guidance working within the Method Operable Design Region which is also known as design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change. newlineQbD method development approach is aligned with the upcoming USP lt1220gt and ICH Q14 guidelines of life cycle management of analytical methods. Based on risk and science-based information, we developed UPLC (Ultra Performance Liquid Chromatography) methods for antipsychotic drugs are developed by applying a Quality by Design approach. A systematic review of all key components of the RP*UHPLC methods was carried out during development in order to create a robust experimental design. Therefore, the developed methods are simple, accurate and precise for both active compounds and degradation compounds. While developing method Platforming approach was used, which means same method can be used for drug substance as well as for drug products. Platforming approach is having implausible advantage in R and D and stability labs to perform comparison and trending of impurity profile in drug substance and drug products throughout the life cycle of product.