Stability Indicating HPTLC Method for Dapoxetine HCL in Bulk and in Formulation

A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of Dapoxetine hydrochloride in bulk and in formulation. Chromatographic separation was performed on aluminum plate precoated with Silica Gel 60 F254 using Ethyl Acetate: Methanol (9:1 v/v) as the mobile phase with saturation time 20 min, followed by densitometric scanning at 239 nm. This system was found to give compact spot for Dapoxetine hydrochloride (Rf value 0.78 ± 0.005) and specificity in accordance with international conference on harmonization (ICH) prescribed stress conditions. The calibration curve was found to be linear between 100-700 ng/band. The proposed method was found to be accurate, precise, reproducible, specific and sensitive and applicable for the determination of Dapoxetine in bulk and in formulation. The drug was subjected to stress condition of hydrolysis (acid, base and neutral), oxidation, photolysis and thermal degradation.