Paper Key : IRJ************040
Author: Ayush Sharma,Priya Ravindra Kamble
Date Published: 29 Oct 2023
Abstract
Teneligliptin is a FDA approved drug for treatment of Diabetes Mellitus. Very few methods have been reported for its stability and identified degradation products. A simple, rapid, precise and accurate stability indicating RP-HPLC method was developed and validated for identification of Inertsil ODS C18 (4.5x250mm)3m was used for the chromatographic separation at a detection wave length of 248 nm. For Buffer solution 0.1% ammonium formate in 1000ml with 3.0 ph with formic acid used and the ratio of 90:10 Buffer: ACN for mobile phase A and 30:70 Buffer: ACN selected as mobile phase B for elution and same buffer was used in the preparation of standard and sample solutions. The elution was monitored by injecting the 10l and the flow rate was adjusted to 1mlmin. The method was validated as per ICH guidelines. Forced degradation studies of Teneligliptin were carried out under acidic, basic, neutral, peroxide, photo and thermal conditions. Degradation was observed in basic, peroxide and neutral stress samples, but not in acid, photo and thermal stress samples.
DOI LINK : 10.56726/IRJMETS45647 https://www.doi.org/10.56726/IRJMETS45647