Teneligliptin

To develop and validate simple, rapid, linear, accurate, precise and economical reverse phase-high-performance liquid chromatography (RP-HPLC) method for of stress degradation study of Teneligliptin. The separation and quantization were achieved on Inertsil C18(250 mm × 4.6ID,5 um ). The mobile phase selected was Methanol: Water (90:10) at a flow rate of 0.8 ml/min and detection of analytes was carried out at 248nm at pH 3. The method exhibited good linearity over the range of 10–50 µg/mL. 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. 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 values of LOD were found to be  0.956  ug/ml for TNG  and the calculated LOQ values were found to be 0.171 ug/ml.

A simple, versatile and a new spectrophotometric method is proposed for the estimation of microgram quantities of the drug Megagliptin.  The drug forms a charge transfer (CT) complex with 2,3-Dichlro-5,6-Dicyano-1,4- Benzoquinone (DDQ), the stoichiometry of which is established as 1:1 by Job’s continuous variation method.   The wavelength of maximum absorbance of the CT complex is found to be 385 nm.  The absorbance values of the CT complex increased linearly with the increase in the amount of the drug Megagliptin upto 300 μg/ml.  This suggests that suitability of the method for the determination of the drug in the range 10 μg/ml to 300 μg/ml.  This also indicates the verification of the Beer-Lambert’s Law in this range.  The method is successfully applied to evaluate the assay of commercial tablets in pharmaceutical formulations for Megagliptin and the results agreed very well.  The molar absorptivity and Sandell Sensitivity of the method are 2.346 x 104  lit. mol-1. cm-1  and 0.01818 μg.ml-1.cm2 respectively.