Stability indicating HPTLC method development and validation for simultaneous estimation of clotrimazole and methylprednisolone aceponate in pharmaceutical dosage forms

We thereby report a simple accurate, precise, specific and stability indicating high performance thin layer chromatographic technique additionally involving forced degradation testing and apparently validate it for the analysis of clotrimazole and methylprednisolone aceponate. Method validated for the simultaneous estimation of clotrimazole and methylprednisolone aceponate in combined pharmaceutical formulations. Chromatographic separation was achieved on pre-coated silica gel 60 F 254 TLC plates using a mobile phase consisting of toluene: chloroform: methanol: ammonia solution (7:2:1:0.2, v/v/v/v). The R f values were found to be 0.64 for CLO and 0.45 for MTA. Densitometric detection was performed at 230 nm. The method exhibited good linearity in the concentration range of 6000–21,000 ng/band for CLO and 600–2100 ng/band for MTA, with correlation coefficients (r²) greater than 0.9970. Validation was carried out according to ICH Q2(R2) guidelines, demonstrating high precision (%RSD < 2), accuracy (recovery between 98 and 102%), and robustness. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the stability-indicating nature of the method, as degradation products were well resolved from the parent compounds. The proposed HPTLC method is rapid, specific, and cost-effective, and can be successfully applied for routine quality control and stability testing of CLO and MTA in their combined dosage forms.