Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy

T N V Ganesh Kumar,Y Sai Silpa,S Vidyadhara,M Rajya Lakshmi,Niteen Ashok Narkhede

doi:10.1186/s40543-016-0107-4

Abstract

Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy

Highlights

Teneligliptin is a new FDA approved drug for treating Diabetes Mellitus
Teneligliptin is a novel drug, which is used for the treatment of type 2 diabetes mellitus
Teneligliptin exerts its activity for 24 h, with elevation of activated glucagon-like peptide 1 (GLP-1) levels by suppressing postprandial hyperglycemia after the meals (Goda and Kadowaki 2013; Ideta et al 2015; Bronson et al 2013)

Summary

Introduction

Teneligliptin is a new FDA approved drug for treating Diabetes Mellitus. There are no reported evidences for its degradation products during stability studies and their effects on humans. Teneligliptin is a novel drug, which is used for the treatment of type 2 diabetes mellitus. It is an antidiabetic drug that belongs to dipeptidyl peptidase-4 inhibitors or “gliptins” (Kishimoto 2013). It is {(2S, 4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1piperazinyl]-2-pyrrolidinyl} (1, 3-thiazolidin-3-yl) methanone (Fig. 1). S conditions as per the ICH guidelines (Asian Guideline for Validation of Analytical Procedure Adopted from ICH guideline and Q2A27, ICH Q2B 1994) and (2) Identification of the degraded products obtained and their characterization using UPLC with tandem mass spectroscopy (LC/MS/MS).

Objectives

Methods

Results

Discussion

Conclusion