A Stability Indicating HPLC Methodology Applying Quality by Design for the Concurrent Estimation of Luliconazole and Clobetasol Propionate in Cream Formulation

ABSTRACT Antifungal agents containing azole ring (luliconazole [LULI]) and corticosteroid (clobetasol propionate [CLOB]) combination shows great therapeutic effects on skin infections by eliminating the fungus that is responsible for the infection and reducing the inflammation of the skin. The research work intended to create a liquid chromatographic methodology with stability study for estimating LULI and CLOB applying design of experiment approach. LULI and CLOB were analyzed utilizing a Hypersil BDS C 18 column (250 × 4.6 mm, 5 µm), using elution solvent comprising 0.1 M sodium phosphate buffer (pH 6.0) combined with methanol in a ratio of 40:60 v/v. The proposed method a flow rate of 1 mL/min and a detection wavelength of 240 nm. A 3 2 full factorial design was utilized to optimize the mobile phase. The methodology had undergone validation using ICH strategies. The study on force degradation was conducted for the cream formulation containing both the drugs. The satisfactory linearity range for LULI was found to be 10–30 µg/mL, whereas 0.5–1.5 µg/mL for CLOB. The method demonstrated good sensitivity, with detection limit and quantification limit of 0.255 and 0.774 µg/mL for LULI along with 0.106 and 0.322 µg/mL for CLOB. The established methodology was found to be precise (%RSD < 2) and accurate (recovery between 98% and 102%). The degradation studies aimed to confirm the efficient separation of LULI and CLOB from their degradation products. From the degradation chromatograms it has been demonstrated that any degradation products, if present, do not interfere with the active constituents.