Spectrophotometric Method Development and Validation for the Estimation of Trelagliptin Succinate in Bulk and Pharmaceutical Dosage Form

Abstract

A Simple, precise and sensitive ultraviolet spectrophotometric method was developed for the estimation of Trelagliptin succinate in bulk and pharmaceutical dosage form, method was run through LABINDIA UV-Visible spectrophotometer-3200 with solvent of acetonitrile was used. In this method working wavelength was selected at 276 nm. The developed method was validated as per the international conference on harmonization (ICH Q2(R1)) guidelines. The drug was obeying Beer-Lambert’s law revealed good correlation in the concentration range of 10 - 60 µg/ml with correlation coefficient (r2) of 0.9993. The validity of the proposed method was assessed by applying the standard addition technique where the percentage recovery of the added standard was found to be 99.97 % for Trelagliptin succinate. The absorbance was found to be 0.0365 - 0.0506 with %RSD for both inter-day precision & intraday precision. The limit of detection and quantification were calculated and was found to be 0.0563 µg/mL and 0.1689 µg/mL respectively. The developed method was successfully applied to the determination of Trelagliptin in commercially available dosage form with percentage assay of 98.52. The proposed method is recommended for routine analysis of Trelagliptin in bulk and dosage forms in quality control testing laboratories. Since it is rapid, simple, accurate and sensitive.