Method development and Validation of Anti-diabetic drug Sitagliptin by UV-Visible spectroscopy using 1,2-napthoquinone-4- sulphonate (NQS) Reagent in Bulk, Dissolution Samples and Biological Samples

A simple and sensitive UV-visible spectroscopic method for the assay of Sitagliptin in pure and pharmaceutical formulations based on the reaction between amino group in the Sitagliptin drug with 1,2-Naphthoquinone-4-sulfonate (NQS) reagent gives coloured complex Sitagliptin + NQS Reagent → Orange coloured Complex The goal of the current work is to establish a trustworthy method for sitagliptin determination utilizing UV spectroscopy. The wavelength at which the sitagliptin exhibited absorption maxima was 454 nm. Sitagliptin has a linearity range of 5-120μg/ml and a correlation coefficient of 0.9975. When sitagliptin was measured precisely, the result was less than 2. The results of the suggested approach were deemed adequate and appropriate for determining sitagliptin for regular quality control of the drug's formulation and bulk supply. The ICH guidelines Q2R1 are followed in the validation of this approach. The protein precipitation extraction method was used to design, validate, and expand the improved procedure to biological material.