Application of Quality by Design Approach in the Optimization and Development of the UPLC Analytical Method for Determination of Fusidic Acid in Pharmaceutical Products

Background: Analytical techniques are a crucial method used in quality control procedures. Fusidic acid (FU), an antibacterial drug, is available on the market in a semisolid dosage form. This work aimed to develop a simple, sensitive, and robust UPLC assay for FU. Method: The effect of the formic acid concentration (X1 (1%, 0.55%, and 0.1%)), and column temperature (X2 (40, 32.5, and 25 ?)) on the retention time, peak area, and peak height were determined. Results: The results show that a long retention time of 1.18 min can be achieved with a low column temperature and a low to medium concentration of formic acid. A good peak height resolution was obtained with a low concentration of formic acid at different temperature settings. The optimized condition was suggested by the software program to analyze the drug in a mobile phase, consisting of 72% acetonitrile and 28% water containing 0.1% formic acid with a column temperature adjusted to 40 ?. Conclusion: The method was validated in terms of linearity, accuracy, precision, and robustness. In addition, the stability degradation study determined that the method can separate the drug from other degradation production. The method was applicable to determine the drug content in the marketed product.

Automated summary

A simple, sensitive, and robust UPLC assay was developed for the determination of fusidic acid. The effect of formic acid concentration and column temperature on retention time, peak area, and peak height was investigated. The optimized condition was found to be a mobile phase consisting of 72% acetonitrile and 28% water containing 0.1% formic acid, with a column temperature of 40?.