Abstract

Development and validation of area under curve method by using first order derivative for estimation of Sitagliptin in tablet dosage form

Author(s): Pritam S.Jain,Amar J.Chaudhari,Amod S.Patil, Sanjay J.Surana

Simple, precise and economical UV spectrophotometric methods have been developed for the estimation of Sitagliptin in pharmaceutical dosage form. Method applied was area under curve (AUC) in which area under curve was integrated in the wavelength range of 271.60 - 278.20 nm. Calibration curves were plotted for method by using instrumental response at selected wavelength and concentrations of analyte in the solution. Linearity for the detector response was observed in the concentration range of 10-60 µg/ml for the method. Tablet formulation was analyzed and % assay determined was 99.44% – 101.68%. Accuracy and precision studies were carried out and results were satisfactory. The results of the analysis were validated statistically. Limit of detection and limit of quantitaiton were determined for methods. The methods were validated by following the analytical performance parameters suggested by the International Conference onHarmonization.All validation parameterswerewithin the acceptable range. The developedmethods were successfully applied to estimate the amount of Sitagliptin in pharmaceutical formulations.