The First Validation HPTLC Method for Simultaneous Estimation of Beclomethasone Dipropionate and Fusidic Acid in Pure and Pharmaceutical Dosage Form

The present work is concerned with the novel, accurate, and precise quantification of beclomethasone dipropionate and fusidic acid in combination (cream), which was performed using high-performance thin-layer chromatography (HPTLC), and validation was performed based on International Council for Harmonization guidelines (Q2 R1). A series of HPTLC tests was conducted on pre-coated silica gel G60 F₂₅₄ plates as the stationary phase and n-hexane:ethyl acetate:toluene:diethyl ether (4.5:5.5:1:0.2, v/v/v/v) as the mobile phase. Chamber saturation time was 30 min to attain the desired results. The R_f of beclomethasone dipropionate and fusidic acid was determined to be 0.52 and 0.36 respectively. The densitometric estimation was performed in reflectance mode at 238 nm. A linear relationship was seen in the range of 0.4–2.0 μg/band for beclomethasone dipropionate and 0.8–4.0 μg/band for fusidic acid with R² of 0.9914 and 0.9927 for beclomethasone dipropionate and fusidic acid respectively. The limit of detection was found to be 0.2653 and 0.27040 for beclomethasone dipropionate and fusidic acid respectively, and the limit of quantification was found to be 0.42065 and 0.81940 for beclomethasone dipropionate and fusidic acid respectively. The percentage recovery was found to be within the range 98–102% for both beclomethasone dipropionate and fusidic acid. The method proposed was determined to be novel, error-free, robust, and reproducible.