QUALITY BY DESIGN DRIVEN ANALYTICAL METHOD VALIDATION
Keywords:
validation, specificity, precision, linearity, LOQ and LOD, QbDAbstract
Introduction of efficient chromatographic and modified spectral techniques has revolutionized analytical method development. There is a rapid and continuous growth in the field of pharmaceutical analysis which has expedited solving the complex analytical problems with improved sensitivity and selectivity in estimation. Analytical method development and validation is an integral part of drug and formulation development and remains vital throughout its lifetime. Analytical methods are developed as quality indicating parameter for new molecules, formulations, process, residues analysis, degradation studies and impurity profiling. This review focuses on understanding and implementing the validation guidelines for analytical methods. Evidently, the concept of quality by design has paved its way in the last decade for in-depth understanding of the method. Moreover, it helps in the development of a robust method and thereby boost confidence in estimation. The current review article discusses various analytical method validation parameters, the way to perform those studies, acceptance criteria for each parameter and the importance and implementation of quality by design in analytical method development and validation and gives insight about the recent publication trends in this regard. From the publication trend of a decade, a significant rise in the analytical method development based on quality based design was observed.
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Copyright (c) 2023 VRUSHALI SACHIN TAMBE, ARCHANA MUKUL KARNIK, REKHA BHALERAO, PRIYANKA MARTAND KOKATE, PRERNA DONGARE
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