Abstract

DEVELOPMENT AND VALIDATION OF STRESS DEGRADATION STUDIES FOR QUANTIFICATION OF TENELIGLIPTIN BY U V SPECTROSCOPIC METHOD

Kalyani V. Tighare* and Amol V. Sawale

Abstract

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for of stress degradation studies for quantification of Teneligliptin. The drug is freely soluble in organic solvents Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done by capillary tube method. It showed absorption maxima was determined in Methanol. The drug obeyed the Beer‟s law and showed good correlation of concentration with absorption which reflect in linearity. The stability studies on the drug were carried out successfully. The drug which when subjected to thermal, photolytic, oxidative, and acidic stress degraded into many degradation products. In most of the cases, the degradation rate was seen to be directly proportional to the amount of stress applied. The thermal stress was increased by increasing the incubation temperature, the faster the degradation took place. The melting point of the pure drug Teneligliptin was determined by capillary tube method. It was found that in between 209 – 2110C. It showed absorption maxima 248 nm in Methanol. On the basis of absorption spectrum the working concentration was set on 10μg/ml (PPM). The linearity was observed between 2-12 μg/ml (PPM). The values of LOD were found to be 5.88 ug/ml for TNG and the calculated LOQ values were found to be 17.29 ug/ml. The low values of LOD and LOQ indicates the sensitivity of the method.

Keywords: Teneligliptin, Validation, force degradation, Methanol, U V Spectrophotomer, Method validation.