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VOL. 10, ISSUE 4 (2025)
A comprehensive review on analytical, stability-indicating, and spectrophotometric methods for the estimation of Trelagliptin Succinate in pharmaceutical dosage forms
Authors
Rujuta Chaudhari, Gavli Jagruti, Patel Dimple, Dr. Deepa Patel, Dr. Ghanshyam Patel
Abstract
Trelagliptin succinate, a long-acting
dipeptidyl peptidase-4 (DPP-4) inhibitor, is widely used for the management of
type-2 diabetes mellitus due to its once-weekly dosing advantage. Accurate
estimation of Trelagliptin in bulk and dosage forms is essential for ensuring
drug quality, safety, and regulatory compliance. This review compiles and
critically evaluates official and non-official analytical methods, including
RP-HPLC, UV spectrophotometry, UPLC, LC–MS/MS, and stability-indicating
studies. Literature from peer-reviewed journals, patents, regulatory documents,
and research projects from 2010–2025 is analyzed. Emphasis is placed on ICH
Q1A(R2) and Q2(R2) guidelines, forced degradation studies, method validation,
and emerging analytical approaches such as QbD and green chemistry. This
comprehensive article aims to support formulation scientists and analytical
chemists in developing robust, accurate, and regulatory-compliant methods for
Trelagliptin succinate.
Pages:55-56
How to cite this article:
Rujuta Chaudhari, Gavli Jagruti, Patel Dimple, Dr. Deepa Patel, Dr. Ghanshyam Patel "A comprehensive review on analytical, stability-indicating, and spectrophotometric methods for the estimation of Trelagliptin Succinate in pharmaceutical dosage forms". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 10, Issue 4, 2025, Pages 55-56
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