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Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TENELIGLIPTIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Vedantika Das*, Bhushan Bhairav and R. B. Saudagar

ABSTRACT

Simple, accurate, precise and economical HPLC method has been developed and validated for the estimation of teneligliptin hydrobromide hydrate (THH) in bulk and tablet dosage form. Separation was achieved on a Prontosil C8 column using a mobile phase consisting of Acetonitrile: Dihydrogen Potassium Phosphate buffer in 60:40 (v/v) adjusted with o-phosphoric acid pH 3.0.Gradient elution at a flow rate of 1ml/min and UV detection at 246nm. Linearity was observed in the concentration range of 30-150 μg/ml. The retention time for Teneligliptin was 2.47 min. The proposed methods were validated according to the ICH guidelines. The developed methods are accurate and precise and can be used for routine quality control analysis of Teneligliptin in bulk and pharmaceutical formulation.

Keywords: Teneligliptin, Method development and validation, UV, Spectrophotometric.


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