ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR TRELAGLIPTIN FORMULATION BY UV SPECTROSCOPY

ABSTRACTA simple, rapid, accurate, precise and economical UV-Visible spectrophotometric method hasbeen developed and validated for the estimation of Trelagliptin, a dipeptidyl peptidase-4 (DPP-4)inhibitor used in the management of Type 2 Diabetes mellitus, in bulk and tablet dosage form.Methanol was selected as the solvent of choice, and the drug exhibited maximum absorbance(λmax) at 276 nm. The method obeyed Beer–Lambert's law in the concentration range of 10–50μg/mL with a regression equation of y = 0.0203x + 0.0030 and a correlation coefficient (R2) of0.9999. The method was validated as per ICH Q2(R2) guidelines for parameters includingaccuracy, precision (intra-day and inter-day), specificity, linearity and robustness. The meanpercentage recovery ranged from 99.94% to 100.30%, confirming the accuracy of the method.Specificity studies demonstrated an uncorrected placebo interference of only 0.125% at 276.6nm, indicating the method is unaffected by formulation excipients. The %RSD values forprecision and robustness studies were less than 2%, indicating high reproducibility. Thevalidated method is simple, cost-effective and suitable for routine quality control analysis ofTrelagliptin in pharmaceutical dosage forms.