Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method

Abstract

A simple, accurate, precise and economical HPTLC and UV method has been developed and validated for the estimation of teneligliptin hydrobromide hydrate (THH) in bulk and tablet dosage form. The chromatographic method employed pre-coated silica gel 60F254 plates using toluene: methanol: triethylamine (8:2:0.2 v/v/v) as mobile phase. The plates were developed to a distance of 8.0 cm at ambient temperature. Experimental conditions such as band size, chamber saturation time, migration of solvent front, slit width, etc were critically studied and the optimum conditions were selected. A TLC scanner set at 254 nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. The system was found to give good result for Teneligliptin at Rf 0.51. The calibration plot was found linear between concentration range 0.5-3 μg/ band and r2 = 0.9993. Method was validated according to the ICH guidelines. In stability testing, teneligliptin was found susceptible to alkali hydrolysis and oxidatative degradation. Because the method could effectively separate the drug from its degradation products, it can be used as a stability indicating method. A UV spectrophotometric method was also developed using methanol as solvent at λ max 247 nm. Beer's law was obeyed in the concentration range of 5-50 μg/ml and r2 = 0.9997. The proposed method was validated according to the ICH guidelines. Therefore, both the methods and stress degradation study can be used for routine quality control analysis of Teneligliptin in bulk and pharmaceutical formulation.