Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Dapagliflozin: Forced Degradation, LC-MS/MS Characterization, and Shelf-Life Prediction

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Published: Dec 4, 2023
DOI: https://doi.org/10.53555/jrtdd.v6i3s.3834
Keywords:
Teneligliptin, Dapagliflozin, RP-HPLC, Forced Degradation, LC-MS/MS.

Main Article Content

Paul Richards M
Sunil Kumar Reddy A
Chowdary G V

Abstract

Reverse-phase high-performance liquid chromatography (RP-HPLC) method was established for concurrent quantification of Teneligliptin hydrobromide hydrate (TEN) and Dapagliflozin propanediol monohydrate (DAPA) in bulk drug substances and their fixed-dose combination tablets. Critical process parameters such as mobile phase composition, pH, and flow rate were systematically varied through design of experiments to optimize resolution and peak symmetry, yielding retention times of 3.12 min (TEN) and 5.34 min (DAPA) at 245 nm detection. Comprehensive validation adhered to ICH Q2(R1) criteria, demonstrating linearity across 5–50 μg/mL, precision with relative standard deviation (RSD) below 1.3%, accuracy within 99–101% recovery, and robust separation of degradation products in stress studies, further characterized by LC-MS/MS for structural confirmation.

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How to Cite
Paul Richards M, Sunil Kumar Reddy A, & Chowdary G V. (2023). Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Dapagliflozin: Forced Degradation, LC-MS/MS Characterization, and Shelf-Life Prediction. Journal for ReAttach Therapy and Developmental Diversities, 6(3s), 942–948. https://doi.org/10.53555/jrtdd.v6i3s.3834
Issue
Vol. 6 No. 3s (2023): Interdisciplinary Approaches to Enhancing Well-Being and Quality of Life
Section
Articles
Author Biographies

Paul Richards M

Research Scholar, JNTUH, Telangana, Andhra Pradesh, India, richie2626@gmail.com

Sunil Kumar Reddy A

Research scientist,  Aurobindo Pharma Ltd., Hyderabad, Telangana, India, asunilkumarreddy@gmail.com

Chowdary G V

Principal , Horizon College of Pharmacy, Hyderabad, Telangana, India, gvchowdary08@gmail.com

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