Analytical Method Validation in Pharmaceutical Research: Compliance with Global Regulatory Standards

Abstract

Abstract Analytical method validation ensures that pharmaceutical testing procedures are suitable for their intended purpose. This paper delves into method validation parameters like accuracy, precision, specificity, linearity, detection limits, and robustness. Guidelines from regulatory bodies including ICH, USFDA, and CDSCO are compared and contrasted. Special attention is given to validation in chromatographic methods such as HPLC and gas chromatography (GC), which are widely used in drug development and release testing. Real-world examples highlight common challenges during validation, such as matrix effects, sample stability, and equipment variability. Strategies for documentation and audit readiness are also provided.

Keywords: Analytical Validation, ICH Guidelines, HPLC, Regulatory Compliance, Pharmaceutical Research