Development of Validated Stability Indicating HPTLC Method and Its Application to the Assay of Formulation and Accelerated Stability Studies of Aceclofenac

A simple validated high performance thin layer chromatographic method was developed for the determination of Aceclofenac in presence of its degradant. Separation of Aceclofenac from the degradant could be achieved using aluminium backed silica gel 60 F254 plate with toluene: ethyl acetate: glacial acetic acid, (6:4:0.02v/v) as mobile phase. Densitometry analysis was carried out at 282 nm. The method showed high sensitivity with good linearity over the concentration range of 0.5 – 4 µg/spot. The method was successfully applied to the analysis of pharmaceutical formulation containing Aceclofenac with excellent recovery. The LOD and LOQ were found to be 0.1 and 0.5 µg/spot. Aceclofenac was subjected to hydrolytic, oxidative, thermal and photolytic degradation. It was found that the drug was highly susceptible to acid hydrolysis. Kinetic investigation of the drug followed pseudo-first order reaction. From the Arrhenius plot the activation energy was found to be 13.19 kcal/mole. Statistical analysis revealed that the developed method is accurate and reliable. Hence it can be used for routine quality control analysis of Aceclofenac in tablet formulation.