Title: ANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION FOR DETERMINATION OF RUPATADINE HCL IN BULK AND FORMULATION BY U.V. SPECTROMETRIC METHOD
Author(s): Daswadkar S.C. and Gajale V.N.
A simple, sensitive, spectrophotometric method in UV region has been developed for the determination of RupatadineFumarate in bulk and tablet dosage form. The method have been developed and validated for the assay of Rupatadine. Solution of Rupatadine Fumaratein Solvent shows maximum absorbance at 273.5 nm in zero order spectrum method, in first order derivative spectra show sharp peak at 261.5 nm, calculation of area under curve (AUC) for analysis of Rupatadine in wavelength rangebetween 268.5 nm to 278.5 nm. The Beer-Lambert’slaw was obeyed in the concentration range of 1 to 6 μg / ml. Result of analysis were validated statically and were found to be satisfactory. Parameters of the analysis were chosen according to ICH [Q2 (R1)] guideline.
Keywords: RupatadineFumarate, UV spectroscopy, Zero order Derivative, First order derivative, Area under curve method.