Abstract

METHOD DEVELOPMENT AND METHOD VALIDATION: AN OVERVIEW

Priyanka Mondal* and Hemendra Pratap Singh

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Abstract

Analytical method development and validation are ongoing processes integral to research and development activities. Method development typically involves defining method specifications and selecting appropriate instrumentation. Analytical methods are crucial for various purposes, including material testing and providing data to support specifications. High-performance liquid chromatography (HPLC) is widely recognized as one of the most accurate methods for both qualitative and quantitative analysis of pharmaceutical drugs. Method validation is the process of demonstrating that an analytical method is appropriate for its intended purpose, a critical step for ensuring analytical reliability. Validation ensures the reliability, consistency, and quality of analytical data, with parameters evaluated including accuracy, linearity, limits of detection and quantification, ruggedness, and robustness. This review highlights different methodologies for pharmaceutical development and discusses various validation parameters.

Keywords: Method development, Validation, Limit of quantitation, Limit of detection, Linearity, Robustness, Ruggedness.