ABSTRACT

Teneligliptin is a Anti-diabetic agent used in the management of T2DM. It belongs to class DPP-4 (dipeptidyl peptidase-4) ihibitors or "gliptins". A simple, accurate and sensitive method has been developed for the estimation of Teneligliptin in pharmaceutical dosage form. The ?max of Teneligliptin was found to be 248 nm in methanol:water pH3 [70:30(v/v)]. The method shows high sensitivity with linearity 10 to 50 µg/ml (regression equation: y = 39069x +38994; r2 = 0.999). The various parameters according to ICH guidelines are followed for validating and testing of this method. The limit of Detection and limit of Quantitation were found to be 0.1756 µg/ml and 0.5321 µg/ml in Methanol: Water pH: 3 [70:30 (v/v)] respectively. The % purity of tablet formulation was found to be 99.8855%. The results concluded that the procedure is accurate, specific and reproducible (RSD < 2%), and also being simple and cheap and appropriate for the determination of Teneligliptin in bulk and pharmaceutical formulation. Keywords: Teneligliptin, RP-HPLC, DPP-4 Inhibitors, ICH Guidelines
Publication date: 01/12/2021

https://ijbpas.com/pdf/2021/December/MS_IJBPAS_2021_DEC_SPCL_2006.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.12.2006