METHOD OPTIMIZATION FOR KETOPROFEN TABLET DISSOLUTION: ENHANCED EFFICIENCY THROUGH MODIFIED TEST CONDITIONS
METHOD OPTIMIZATION FOR KETOPROFEN TABLET DISSOLUTION: ENHANCED EFFICIENCY THROUGH MODIFIED TEST CONDITIONS

Summary/Abstract: The continuous advancement of the pharmaceutical industry is not only marked by the discovery of novel therapeutic agents and innovative dosage forms but also by the need to improve existing analytical methodologies, especially those involved in process quality control. In modern pharmaceutical development, rapid, cost-effective, and reliable analytical techniques are essential to ensure the consistent performance and therapeutic efficacy of marketed drug products. One of the critical parameters in evaluating the bioavailability and therapeutic potential of solid oral dosage forms is their dissolution behavior, which directly correlates with drug solubility under physiologically relevant conditions. This research paper focuses on the optimization and modification of an existing UV-Vis spectrophotometric method for testing the dissolution of ketoprofen in tablet formulations, with the goal of simplifying and accelerating the dissolution testing protocol. The study involved the deliberate modification of several test conditions, including the pH of the dissolution medium (adjusted from pH 7.2 to pH 6.8), the rotation speed (reduced from 100 rotations per minute (rpm) to 75 rpm), and the sampling time points (shifted from a single 45 minute time point to three intervals of 15, 30, and 45 minutes). The choice of these parameters was based on their relevance to both physiological conditions and analytical efficiency. The results demonstrated that the modified method produced more favorable dissolution profiles, with significantly improved average solubility of the active pharmaceutical ingredient (API) even after just 15 minutes of testing. Such a rapid and consistent dissolution rate not only ensures better prediction of in vivo behavior but also offers a practical advantage for routine quality control testing by reducing analysis time without compromising reliability. Furthermore, this study highlights the need for ongoing evaluation and refinement of existing pharmacopoeia methods, recognizing that established procedures may benefit from scientifically supported improvements. The findings support a more flexible approach to method development, where alternative techniques when properly validated in line with official pharmacopeia standards can be considered for routine use. The study also emphasizes the broader relevance of method optimization in pharmaceutical analysis, demonstrating how minor but deliberate modifications to test conditions can lead to meaningful improvements in accuracy, speed, and efficiency. In conclusion, the proposed dissolution testing method presents a viable and promising alternative for the routine analysis of ketoprofen tablets, offering enhanced operational efficiency, practical utility, and alignment with modern industry demands for rapid, reliable, and cost-effective quality control strategies

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