A QBD Approach in Chemometric assisted Method Development of Telmisartan and Amlodipine besylate by UV-VIS Spectrophotometry

Abstract

Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying QbD approach chemometric based analytical method was developed for the estimation of amlodipine besylate and telmisartan by UV-VIS spectrophotometry. Solvent 0.1 N HCl was utilised and 291.2 nm and 365.2 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 5-40mcg/ml. The accuracy was found 104.46% for TEL and 96.25% for AMD; and the precision study was shown acceptable data as %RSD 2.5416 for TEL and 5.7364 for AMD. The developed method is rigid, robust and efficient for the estimation of AMD and TEL, which are in 1: 8 proportionate in the composition of dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.