Development and validation of HPTLC method for estimation of Darifenacin Hydro bromide in Pharmaceutical formulation

A specific, accurate, precise and robust HPTLC method was developed and validated for estimation of darifenacin hydrobromide in pharmaceutical formulation. In this method, standard and sample solutions of darifenacin hydrobromide were applied on pre-coated silica gel 60F254 TLC plate and developed using Toluene: Methanol: Acetone: Triethylamine [7: 1.5: 1.5: 0.2, % v/v/v/v] as mobile phase. A Camag HPTLC system comprising of Camag Linomat V applicator, Camag twin trough chamber and Camag TLC IV scanner was used for the analysis. The spots were scanned at 286 nm. The linearity range was achieved in range of 50 to 250 ng/spot. The method was validated as per ICH Q2(R1) guidelines and applied for assay of darifenacin hydrobromide in its marketed formulations.