Preformulation Studies And Simultaneous Estimation Of Fusidic Acid And Diclofenac
Abstract
Aim: This study aims to perform comprehensive Preformulation studies and develop a validated analytical method for the simultaneous estimation of Fusidic Acid and Diclofenac. These two drugs, widely used in dermatological and anti-inflammatory therapies, require precise formulation strategies to ensure stability, efficacy, and patient safety.
Method: The Preformulation studies included evaluating the physicochemical properties of Fusidic Acid and Diclofenac, such as solubility, pH stability, and thermal stability. Drug-excipient compatibility was assessed using Fourier-transform infrared spectroscopy (FTIR). For simultaneous estimation, a UV-Visible spectrophotometric method and a High-Performance Liquid Chromatography (HPLC) method were developed and validated in accordance with ICH guidelines. Parameters such as linearity, accuracy, precision, and robustness were evaluated.
Results: Fusidic Acid and Diclofenac exhibited distinct solubility profiles, with optimal solubility observed in specific pH environments. Both drugs were found to be stable under various temperature conditions. The FTIR studies confirmed no significant interactions between the drugs and selected excipients, indicating compatibility. The HPLC method developed showed excellent linearity over the concentration range of 5-60 µg/mL for both drugs, with correlation coefficients (R²) greater than 0.998. The method was precise, with intra- and inter-day variability below 2%.
Conclusion: The Preformulation studies provided critical insights into the physicochemical properties and stability of Fusidic Acid and Diclofenac, facilitating their co-formulation. The validated HPLC method proved to be a reliable tool for the simultaneous estimation of these drugs in combination formulations, supporting further development of combination therapies. These findings pave the way for the formulation of effective and stable pharmaceutical products containing Fusidic Acid and Diclofenac.
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