ABSTRACT Clotrimazole (CLOT) is an antifungal and mometasone furoate (MOMF), a corticosteroid used to treat skin infections effectively by killing the pathogenic fungus and reducing inflammation. This work aimed to develop a stability‐indicating liquid chromatographic method for the concurrent quantification of MOMF and CLOT employing a design‐of‐experiment strategy. The elution solvent used to test CLOT and MOMF was a combination of 60:40 v/v acetonitrile and phosphate buffer (pH 4.0). A Shimpack ODS C18 column (4.6 mm × 250 mm, 5 µm) was utilized for this purpose. This approach was tested with a detection wavelength of 249 nm and a flow rate of 1 mL/min. The mobile phase was optimized utilizing a 3 2 full factorial design (quadratic model). The International Conference on Harmonization strategies were used to validate the methodology. The cream formulation comprising both the drugs underwent force degradation study. CLOT was determined to have an acceptable linearity range of 50–600 µg/mL, whereas MOMF had a linearity range of 5–60 µg/mL. The method demonstrated good sensitivity, with detection limit and quantification limit 3.97 and 12.04 µg/mL for CLOT along with 1.14 and 3.45 µg/mL for MOMF. The established methodology was determined to be both accurate (recovery between 98% and 102%) and precise (% RSD < 2). The degradation studies aimed to confirm the efficient separation of CLOT and MOMF from their degradation products. Chromatograms of stressed samples confirmed that degradation products did not interfere with the peaks of the active components.
Dash et al. (Wed,) studied this question.