Development and Validation of Stability Indicating HPTLC Method for Simultaneous Estimation of Fluocinolone Acetonide and Miconazole Nitrate in Ointment

Fluocinolone acetonide is a steroidal drug and Miconazole nitrate is an antifungal azole. The combination of these drugs has a highly beneficial effect on dermatological inflammatory disorders associated with fungal infections. A simple, specific, accurate, precise, robust and stability indicating HPTLC method has been developed and validated for the simultaneous estimation of Fluocinolone acetonide and Miconazole nitrate in bulk drug and ointment dosage form. Chromatography was performed using pre-coated silica gel aluminium plate 60F254, (10 ×10 cm) as stationary phase and n-Hexane: Ethyl acetate (1:9, v/v) as mobile phase. Detection was carried out at 254 nm. The Rf value for Miconazole nitrate and Fluocinolone acetonide was found to be 0.46 and 0.64 respectively. The optimized conditions develop showed a linear response from 200-700 ng/spot (r2 =0.983) for Fluocinolone acetonide and 40000-140000 ng/spot (r2 =0.990) for Miconazole nitrate. The study involved observation on degradation products formed under different stress condition. The developed method successfully separated drug substances from degradation products formed under various stress conditions.