Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors : Dr. Ananya Sharma, Mr. Vikram Joshi

Abstract: Analytical method validation is a critical component of pharmaceutical analysis that ensures the reliability, accuracy, and reproducibility of results. According to International Conference on Harmonization (ICH) guidelines, validation involves systematic evaluation of parameters including specificity, linearity, accuracy, precision, detection and quantification limits, robustness, and system suitability. This paper reviews the principles, procedures, and applications of analytical method validation in pharmaceutical quality control. Various chromatographic, spectroscopic, and titrimetric methods are discussed, along with their validation strategies. Emphasis is placed on the integration of ICH guidelines into routine laboratory practice for regulatory compliance. Tables summarizing validation parameters, techniques, and quality control criteria are included. Challenges such as matrix effects, instrumental variations, and method transfer are discussed. The study highlights the significance of validated analytical methods in ensuring drug quality, safety, and efficacy throughout development and manufacturing.

Keywords: Analytical Method Validation, ICH Guidelines, Specificity, Accuracy, Precision, Linearity, Robustness, Pharmaceutical Analysis