In-Vitro Dissolution Comparison between Two Commercially Available Brands of Diclofenac Sodium Sustained Release Tablets

Abstract

This research focuses on the comparative evaluation of the in-vitro dissolution profiles of two commonly available sustained-release diclofenac sodium (50 mg) tablet brands in the Indapur region. The dissolution studies were conducted using the USP Type II (paddle) apparatus, adhering to pharmacopeial guidelines. Initially, the tablets were exposed to an acidic environment to simulate stomach conditions, followed by testing in a phosphate buffer (pH 6.8) to represent intestinal conditions. According to the USP standards, each formulation must release at least 75% of the drug within 12 hours in the phosphate buffer phase. Drug release was measured using UV spectrophotometry at a wavelength of 277nm, with the analytical method’s accuracy and linearity validated for reliability. Both brands demonstrated similar dissolution profiles, suggesting their comparable performance. This study highlights the importance of evaluating both the percentage of drug release and the complete dissolution profile, which are critical for quality control practices to ensure that generic formulations meet the efficacy and safety standards of their branded equivalents.