A Review on Dissolution Method Development and Validation

Abstract

Dissolution testing is an essential part of the pharmaceutical quality assurance process, measuring the rate and extent to which the active pharmaceutical ingredient (API) is released from its dosage form in vitro. It is a key determinant of drug bioavailability and, by extension, therapeutic efficacy. With its pivotal role in drug development, dissolution testing requires precise development and validation of methods to ensure consistency, reliability, and compliance with regulatory standards. This review explores the fundamental elements of dissolution method development, including the selection of dissolution medium, apparatus choice, and design parameters that influence dissolution outcomes. Additionally, the review addresses validation protocols necessary to confirm specificity, accuracy, precision, and robustness, as per guidelines from the United States Pharmacopeia (USP), Food and Drug Administration (FDA), and International Council for Harmonisation (ICH). Further, advancements in automation are discussed, demonstrating how modern technologies enhance efficiency, reproducibility, and regulatory compliance. By synthesizing current practices and standards, this review serves as a guide for researchers and professionals engaged in the development and validation of dissolution methods, outlining best practices, key challenges, and future directions.