Rp-HPLC Method Development and Validation of Teneligliptin and Metformin in Pharmaceutical Dosage Forms

Abstract

The aim of the present study was to develop and validate a simple, rapid and reproducible gradient high performance reverse phase liquid chromatography method for the estimation of Teneligliptin and Metformin in bulk drug sample and pharmaceutical dosage forms u sing Cosmosil (C18, 250X4.6mm, 5μm) column with mobile phase composition of methanol and water (pH 3.5) 50:50 v/v. Flow rate of 0.7ml/min and uv detection at 242nm was maintain during the entire study. The retention time for Metformin and Teneligliptin was found to be 2.45 min and 6.21 min respectively. Linearity was observed over concentration range of 2-10μg/ml and 50-250 μg/ml for Teneligliptin and Metformin respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98-101%. The proposed method was validated and results conformed to ICH parameters.

Chemometric Assisted Method Development for Teneligliptin and Metformin by Stability Indicating RP-HPLC Technique and its Validation

“…Moreover, many methods were reported for the estimation of metformin along with other drugs in combined formulation [29][30][31][32][33][34][35][36][37]. Analytical methods for the estimation of teneligliptin and metformin simultaneously are three different UV spectrophotometers [38], RP-HPLC methods [39][40][41]. There are few methods available in the literature for simultaneous estimation of teneligliptin and metformin in combined dosage form, but by applying statistical tools to the method development by RP-HPLC has not yet been reported by any method.…”