Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION – A REVIEW

Mahamood Basha G. and Sheela Rani T.*

ABSTRACT

Analytical method development and validation plays a crucial role in ensuring the accuracy, reliability, and fitness-for-purpose of quantitative analytical techniques. It provides an overview of the key elements and significance of method validation, focusing on the pharmaceutical industry. The validation procedure systematically assesses diverse performance parameters to establish the suitability of an analytical method for its intended application. These parameters include specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), limit of quantification (LOQ), and stability. Each parameter is assessed through a series of experiments, following established guidelines such as those provided by regulatory authorities, industry standards, or scientific organizations.

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