A novel spectrophotometric method development and validation of Tenagliptin in its Tablet dosages form

Abstract

The aim of present work was to develop a new, economical & simple analytical method of Teneligliptin & its validation as per International Conference on Harmonization (ICH) guideline, which is a new antidiabetic drug that is used to treat Non-Insulin Dependent Diabetis Melitus (NIDDM) patients. A sensitive and specific Ultra Violet (UV) Visible method was developed & the analysis was carried out by using Shimazdu 1800 Spectrophotometer, 0.1(N) NaOH was used as a solvent. The UV- Visible Spectrophotometric estimation was carried out at a λ max of 242 nm using 1cm thick quartz cell. Validation of the newly developed method was performed as per International Conference on Harmonization (ICH) Q2R1 guideline in the following parameters: Calibration curve, Accuracy, Precision etc.  Newly developed method obeys Beer’s-Lambert’s law in the concentration range of 5 - 25 μg / ml, whereas correlation coefficient value is less than 1. The percent amount of drug estimated by this developed method was 100.91 %, which is very close to 100 %. The validation parameters like Accuracy, Precision, Linearity, Range, Limit of detection (LOD) & Limit of Quantification (LOQ) were studied for the developed method and was found to be within the limits. Keywords: Teneligliptin, Validation, Method, Spectroscopy etc.