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ISSN 2063-5346
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METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION BEHAVIOR OF TENELIGLIPTIN AND REMOGLIFLOZIN ETABONATE IN COMBINED DOSAGE FORM BY RP-HPLC METHOD

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Kamalakannan Dhanabalan, Manivannan Rangasamy, Suresh Kumar Gopal, Arun Sivalingam, Bharath Prasath Jeeva, Dhivyabharathi Venkatesh, Gokul Raj Ayyandurai, Hariprasath Loganathan, Deepika Vishwanathan
» doi: 10.31838/ecb/2023.12.s3.025

Abstract

A simple, accurate, precise method was developed for the simultaneous estimation of the Teneligliptin (TEN) and Remogliflozin etabonate (REM) in tablet dosage form. Chromatogram was run through Standard kromasil C18 (4.6x150mm,5μm). Mobile phase containing Acetonitrile: KH2PO4 taken in the ratio 65:35 v/v was pumped through column at a flow rate of 1 mL/min. Buffer used in this method was Phosphate buffer and pH was adjusted to 5.4 by adding 0.1% Formic acid. Temperature was maintained at 30°C. Optimized wavelength selected was 228 nm. Retention time of Remogliflozin etabonate and Teneligliptin were found to be 2.263 min and 2.994 min. %RSD of the Remogliflozin etabonate and Teneligliptin were and found to be 0.9 and 0.4 respectively. %Recovery was obtained as 100.21% and 100.08% for Remogliflozin etabonate and Teneligliptin respectively. LOD, LOQ values obtained from regression equations of Remogliflozin etabonate and Teneligliptin were 0.26, 0.78 and 0.03, 0.09 respectively. The developed method was validated as per ICH Q2 (R1) guidelines. Regression equation of Remogliflozin etabonate was y = 24560x + 3087 and y = 40746x + 617.4 for Teneligliptin. The method developed was found to be robust. The drug samples were also subjected to forced degradation conditions such as acid, base, peroxide, thermal, UV and water.Retention times were decreased and that run time was also decreased. Hence the proposed simultaneous estimation was accurate, specific, reproducible and economical that can be adopted in regular Quality control analysis in Pharmaceutical Industries.

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