Method development and validation of aliskiren in tablet formulation by UV spectrophotometric methods

Optical methods through ultraviolet-spectrophotometer were developed and justification was done to validate the method for quantitative determination of aliskiren in its tablet formulation. Wavelengths for different methods were chosen by running selected sample in spectrum mode of the instrument, it was 279 nm; absorbance maxima for zero order technique, 289 nm; peak minima for first order derivative technique and between 269 nm and 289 nm for AUC technique using distilled water as reference. After studying linearity graph, working concentration range selected for method I, method II and method III was in between 25 to 150 µg mL-1. R2 value equal to 0.999 confirmed a better correlation between concentration and absorbance. Percentage purity of aliskiren in tablet formulation was found in between 98.54-100.36 which was very close to label claim. Validation following ICH guidelines was done to justify the results obtained through method I, method II and method III. The percentage of the standard drug recovered in recovery study for all the three techniques were within the limit and were in between 98.61-101.66. The percentage relative standard deviation in precision study was less than 2 for all the techniques. From the observed data it can be said that the developed methods can be utilized for quantitative estimation of aliskiren in tablet formulation. Keywords: Ultraviolet-Spectrophotometer, Optical methods, Aliskiren, Validation, First order derivative, AUC