A validated, stability-indicating HPTLC method for analysis of doxofylline

Abstract

A simple, sensitive, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of doxofylline as the bulk drug and in formulations has been developed and validated. The method used aluminum plates coated with silica gel 60 F 254 as stationary phase and toluene-methanol 8:2 ( v/v ) as mobile phase, followed by densitometric measurement at 254 nm. The R F value of doxofylline was 4.3. The drug was subjected to acidic, alkaline, oxidative, and photolytic stress to establish a validated stability-indicating HPTLC method. The method was validated in accordance with ICH guidelines; there was no chromatographic interference from tablet excipients. The drug was found to be stable under wet and dry heat conditions. Because the method could effectively separate the drug from its degradation products it can be regarded as stability-indicating.