Derivative Spectrophotometric Method Development and Validation for the Estimation of Evogliptin Tartrate in Pharmaceutical Dosage Form

Abstract:

Aim: A simple and economic method was developed as a derivative spectrophotometric study for estimation of evogliptin tartrate in the tablet dosage form. The developed derivative method was validated as per the ICH guideline. Materials and Methods: The maximum absorption of evogliptin tartare was found to be 267 nm and its first and second derivative wavelengths were measured at 275 nm and 277 nm respectively. Water was used as a solvent for all measurements. Results: The developed method was shown linear in the concentration range of 20-120 μg/ml for evogliptin tartrate and shows a good correlation coefficient. The precision of the developed method was less than the maximum allowable limit (% RSD < 2) specified by the ICH guidelines. Excellent % recovery (98% - 101%) with less than 2% RSD value indicates method was accurate. Conclusion: The developed UV – Visible method was simple eco-friendly, precise and accurate as per ICH guidelines. The proposed method will use in quality control for routine analysis of evogliptin tartrate in the pharmaceutical dosage form.

Keywords: Derivative method, Evogliptin tartrate (EVO), First derivative, Spectroscopy method, UV-visible method, Validation.